INTRODUCTION:

Tuberculosis (TB) has existence since 1000 years and is considered as a major health problem.¹ It is a type of infectious disease caused by the Bacillus Mycobacterium Tuberculosis, typically affecting the lungs (Pulmonary TB) but can also affect other sites (Extra Pulmonary TB).² It is one of the top 10 causes of ill health leading to death worldwide and ninth leading cause of death from a single infectious agent, which is greater than the HIV virus. Despite from these facts, proper diagnosis and treatment of the disease will cure it completely. For this the World Health Organization (WHO) implemented the End Stage TB strategy in 2014, with milestones and goals to degrade the organism in the upcoming decades. Therefore the DOTS strategy is effectively provided, their funding and availability is highly concerned by the respective governments.¹ Tuberculosis is a communicable, airborne, chronic granulomatous bacterial infection diseases which is mainly caused by the Mycobacterium Tuberculosis and sometimes by Mycobacterium Africanum, Mycobacterium bovis, and avium complex.² This infectious disease is transmitted by the exposure to the organism in air-borne droplet nuclei produced by the infected persons. After inhalation of the bacilli into the body, it gets accumulated in the lungs. In susceptible individuals, the Tuberculi Bacilli multiplies by the normal host defense mechanisms of the body. These are then phagocytized by the macrophages and dendritic cells, they continue activating and multiplying. Based on this, there are two TB related conditions, the Latent TB infection and the Active TB disease. The latent form is the condition by which the affected person does not feel any sick and do not have symptoms but they show positive reaction to tuberculin skin test or blood test. The form is not infectious but when the bacteria overcome the defense mechanism of the immune system, it begin to multiply and generates symptoms which results in the progression of latent to the active form of TB.³ TB affects almost all organs. Based on this, it is classified into two categories. Pulmonary TB (PTB) and Extra Pulmonary Tuberculosis (EPTB). Pulmonary tuberculosis includes PTB Pneumonia, Tuberculosis Pleurisy, Cavitary TB, Miliary TB and Laryngeal TB. EPTB occurs primarily in immunocompromised patients which includes Lymph Node Disease, TB Peritonitis, TB Pericarditis, Osteal TB, Adrenal TB, TB Meningitis.⁴ Regarding the treatment of tuberculosis, two categories of drugs are available, first line agents include Isoniazid, Rifampicin, Pyrazinamide, Ethambutol and second line agents include Fluoroquinolone antibiotic, injectable Aminoglycosides, Capreomycin, Cycloserine and Para-Amino salicylic Acid (PAS) .⁵ This includes the standard and short-course therapy which is divided into two phases - the Initial or Bactericidal Phase and the Continuation or Sterilizing Phase. The initial phase consisting of 4fixed dose combination of Isoniazid, Rifampicin, Ethambutol, Pyrazinamide for 2 months, dose depending upon the weight, along with the continuation phase for 4 months avoiding pyrazinamide, which is termed as Category 1 (CAT-1) therapy. Category 2 (CAT-2) involves the drugs same as the CAT-1 including an injectable aminoglycoside - streptomycin. The CAT-2 is provided in retreatment or relapse cases. Other forms of DOTS are the Multi-drug-resistant (MDR) category, which is initial when the patients is having resistance to 1st line agent and Extensively Drug Resistant TB (XDR) category in which the patients is resistant to both 1st line and 2nd agents. The dose is irrespective from the RNTCP guidelines and administered based on the body weight of the patient.³ Management of this 2 categories is complicated as this involves adjustments in doses and require an expertise monitoring and therapeutic consideration. DOTS therapy was initiated to the need of patients and to the working conditions of medical professionals, which is the only method for the smooth success of the treatment. However, even though with this also exists certain drawbacks, which pulls back the patients towards the treatment completion. This leads to interruption of the therapy, which takes place in both the initial phase and continuous phase.²

According to WHO “A Default is defined as the patient whose treatment was interrupted for 2 consecutive months or more”. It is also known as lost-to-follow up.⁶ This leads to resistance to the drug causing MDR-TB and also XDR-TB, increases the risk of morbidity, mortality and spread of disease in the community. This leads to non-adherence to the treatment. Reasons to this factors are to be considered as a major barriers to treatment. Compliance to this is one of the major factor to overcome the default.⁷According to WHO an ADR is “Any response to drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease, or for modification of physiological function”. This causes both burden for the treatment and cause danger to the patients in relieving the disease, hence it cause to non-adherence to the treatment. This affects the quality of life of the patients.⁶The majority of the ADRs occurs at the first three months therapy, i.e. usually in the initial phase. Chances are more to have ADR in the administration of first doses.40This includes hepatotoxicity and peripheral neuropathy caused by Isoniazid. Hyperuricemia and even hepatotoxicity in pyrazinamide whereas Ethambutol may cause optic neuritis in less common rifampicin causes flu like syndrome, thrombocytopenia, hepatotoxicity discoloration of rifampicin. DOTS in common cause gastric problems, liver dysfunction, arthralgia, neuropathy etc. So proper monitoring and its management helps to avoid defaulting the treatment.⁸This can be initiated by Pharmacovigilance, a sector in healthcare which deals with detection, assessment and prevention of adverse effects of medicines. In India, the Ministry of Health and Family Welfare, a Government of India undertaking, implemented the National Pharmacovigilance Programme (NPV) on 23rd November 2004 at New Delhi. The main aim of the programme was to provide awareness on the importance of ADR monitoring and its reporting to health care professionals. This includes different scales such as the causality, preventability and severity of the ADR. It is reported and monitored in systemic way. The causality assessment can be done by using two scale: WHO causality scale and Naranjo probability scale. The severity assessment of ADR is done by using Hartwig severity scale. The preventability of ADRs is determined by using Modified Shumock and Thornton’s scale.⁹

In the current scenario of high tuberculosis incidence and though it is an infectious disease, involvement of clinical pharmacists in identifying the reasons to default and making an impact towards it could be beneficial to achieve better therapeutic outcome. Though DOTS is more accurate in its programme, a vast country like India requires plenty of attention to the treatment seekers till the last date of the drug intake by the patient and also proper monitoring and preventing of ADR should be enlightened to the patient for the complete success of the treatment. Thus it is of prime importance that a study like this has to be conducted at the primary level. For this purpose, the study was conducted in a tertiary care hospital of Mangaluru, the complete patient related data associated with the disease and proper interview of the patients was conducted to obtain the relevant information on their drug intake pattern.

MATERIAL AND METHODS:

A prospective observational study was carried out in the Pulmonary Medicine department, Justice K.S Hegde Charitable Hospital. Mangaluru, in Dakshina Kannada district of South India. Central research ethics committee approval was obtained before starting the study. The study includes all Hospitalized and out patients of either gender aged above 18 years who are under the treatment of tuberculosis with DOTS therapy. Pregnant patients, Patients who are mentally challenged, Patients who are not willing to participate in the study were excluded from the study. Patient data collection form was designed as per the need of study. Approval was taken from Institutional Ethics Committee and an informed consent was taken from the patients before initiating the study. Data collection form includes details such as patients initial, age, gender, admission date, discharge date, domiciliary status, past medical and medication history, social habits, lab investigations, information about drug therapy (name of drug, dosage form, frequency, route of administration and duration of treatment) etc. The patient enrolled for the study were interviewed using the patient interview sheet when they came for the review or after one month of treatment either by directly interview to the patient or bystander or by means of telephonic conservation. Based on the interview, the knowledge assessment and treatment assessment were marked 1 for correct answers and marked 0 for wrong answers. The knowledge assessment were categorized by marks as 0-2 as below average, 3-5 as average, 6-7 as good knowledge and 8-10 as excellent knowledge. All the data’s were summarized to frequencies with percentage to analyze the findings. Mean and standard deviation was used to summarize age of the patients. All analysis was done by using Statistical Package for Social Sciences (SPSS version 16.0).

RESULTS:

During the study period, a total of 94 patients were prescribed with DOTS therapy, of which 4 people died and remaining 90 patients were enrolled and assessed for the study. Out of 90 patients, 21 patients interrupted the treatment, of which 12 were defaulters. The overall percentage of the default to the treatment was 13.3%. The case fatality rate was 4.4%.

Demographic details of the patients:

Age wise distribution of patients:

According to the age group they were aged from 18-80 years of age with mean value of 45.4 +17.2 standard deviation. The highest number of defaults was reported in the age group of 60-69 years (41.7%), followed by 30-49 years (25%). The distribution of age groups are summarized in the table 1.

Table1 distribution of patients according to age groups

Age Group (Years)	With Defaulters (n=12)	Without Defaulters (n=78)	Total (n=90)
18-29	1 (8.3%)	18 (23.1%)	19 (21.1%)
30-49	3(25%)	31 (39.7%)	34 (37.8%)
50-59	2(16.7%)	13 (16.7%)	15 (16.7%)
60-69	5 (41.7%)	10 (12.8%)	15 (16.7%)
>70	1 (8.3%)	6 (7.7%)	7 (7.8%)

Gender wise distribution of patients:

From the study subjects, 49 (54.4%) patients were males and 41 (45.6%) patients were females. Out of the 12 defaulters, 8 (66.7%) were males and 4 ((33.0%) were females. The distribution of gender are summarized in the table 2.

Table 2: Gender wise distribution of patients

Gender	With Defaulters (n=12)	Without Defaulters (n=78)	Total (n=90)
Male	8 (66.7%)	41 (52.6%)	49 (54.4%)
Female	4 (33.3%)	37 (47.4%)	41 (45.6%)

Distribution of domiciliary status among the patients:

As per the domiciliary status, 56 patients (62.2) belonged to the rural background whereas 30 patients (37.8%) belonged to the urban setting, of which rural placed highest among defaults (8 patients). The distribution of domiciliary status are summarized in the table 3.

Table 3: Distribution of Domiciliary Status among the patients.

Domiciliary Status	With Defaulters (n=12)	Without Defaulters (n=78)	Total (n=90)
Rural	8 (66.7%)	48 (61.5%)	56 (62.2%)
Urban	4 (33.3%)	30 (38.5%)	34 (37.8%)

Distribution of educational status among the patients.:

As per the educational status, 20 patients (22.2%) were illiterates, 35 patients (38.9%) pursued primary education, 29patients (32.2%) pursued secondary education and 6patients (6.7%) of them were graduates. Patients pursuing primary education (58.3%) were found as highest group in defaults. The distribution of educational status are summarized in the table 4.

Table 4: Distribution of educational status among the patients.

Education	With Defaulter (n=12)	Without Defaulter (n=78)	Total (n=90)
Illiterate	2 (16.7%)	18 (23.1%)	20 (22.2%)
Primary Education	7 (58.3%)	28 (35.9%)	35 (38.9%)
Secondary Education	3 (25%)	26 (33.3%)	29 (32.2%)
Graduate	-	6 (7.7%)	6 (6.7%)

Distribution of patients according to their social habits:

It was found that 23 patients (25.6%) had social habits. Of which 10 patients (11.1%) were smoker, 6 (6.7%) patients were alcoholic, among these 3 patients were defaulters and 7 (7.8%) patients had the habit of both alcoholic and smoking. The distribution of social habits are summarized in the below table 5.

Table 5: Distribution of social habits among the patients

Social Habits		With Defaulters (n=12)	Without Defaulters (n=78)	Total (n=90)
Smoker	Yes	-	10 (12.8%)	10 (11.1%)
Smoker	No	12 (100%)	68 (87.2%)	80 (88.9%)
Alcoholic	Yes	3 (25%)	3 (3.8%)	6(6.7%)
Alcoholic	No	9 (75%)	75 (96.2%)	84 (93.3%)
Both	Yes	1 (8.3%)	6 (7.7%)	7(7.8%)
Both	No	11 (91.7%)	72 (92.3%)	83 (92.2%)

Distribution pattern of tuberculosis disease among the patients:

From the study subjects, 54 (60%) of the cases were PTB, 33 cases (36.7%) were EPTB and 3 of them were MDR-TB. Out of 12 defaulters 8 cases (66.7%) were PTB and 4 cases were EPTB. Details are depicted in figure 1.

Figure 1: Distribution of type of tuberculosis.

Incidence of comorbidities among the patients.:

From the 90 patients, 35 (38.9%) came with a total of 54 comorbid conditions. Type 2 Diabetes mellitus (DM) was reported with 23 subjects (42.5%), which was the highest among the subjects followed by hypertension with 10 patients (18.5%). The following Table 6 shows the summarized comorbidities of the study population.

Table 6 Comorbidities among the patients.

Co-Morbidities	Frequency (n=54)	Percentage (%)
Type II DM	23	42.5
Hypertension	10	18.5
HIV Infection	3	5.5
Infectious Diseases	3	5.5
Blood Disorders	3	5.5
Liver Diseases	1	1.8
Renal Disorder	2	3.7
Respiratory diseases	3	5.5
Carcinoma	2	3.7
G.I Disorders	1	1.8
Neurological disorders	2	3.7
Thyroid Disorder	1	1.8

Distribution of treatment regimen among the patients.:

Among the 90 patients who received the DOTS treatment for tuberculosis, 78 patients (86.7%) received CAT I DOTS regimen, 9 patients (10%) received CAT II DOTS and 3 patients (3.3%) received MDR-TB regimen. Details are depicted in the figure 2.

Figure 2: Distribution of treatment regimen among the patients

Distribution of concomitant drugs used along with dots therapy:

From the 90 patients, a total of 311 concomitant drugs was seen in the prescription along with DOTS therapy of which 71 were cough medications, 134 were supplemented drugs, 78 were anti-ulcer drugs, 28 were drugs used for pain management. Among cough medications 44 drugs were pre-antibiotics and 27 drugs were expectorants. The figure 3 depicts the summarized details of the concomitant drugs used along with DOTS therapy.

Figure 3: distribution of concomitant medications

Assessment of the details provided through patient interviewing:

The patient interview was done in order to evaluate the status of the DOTS programme of the study subjects. For this an interview format with questions as three parts was prepared and validated. This included knowledge assessment which involves information regarding the medicine and dots treatment of the study subjects, general assessment involving the information of the patient status towards the DOTS programme, treatment assessment involving information of patient’s treatment condition.

Distribution of knowledge assessment of tuberculosis in the patients.:

Out of the 90 patients interviewed, 48 patients(53.3%) had a good knowledge on the disease of which 1 patient was a defaulter, 12 patients (13.4%) had excellent knowledge, 27 patients (30%) had average knowledge out of which 8 was defaulters and 3 patients (3.3%) was having only below averaged knowledge about the disease were defaulters and the DOTS programme. Details are depicted in the figure 4

Fig 4: Distribution of knowledge assessment of tuberculosis in the patients.

Distribution of general assessment of the patients.:

From the study subjects, the distance for the patients to get the medicines ranged from 0-2kms for 33 patients (36.7%), 5-10kms for 28 patients (31.1%), less than 10kmsfor 22 patients (24.4%) and more than 10kms for 7 patients (7.8%). The problems to get the medicines were distance and transport for 17 patients (18.9%), staying alone for 10 patients (11.1%), time for 8 patients (8.9%) and workload for 9 patients (10%). The DOTS providers attitude was dissatisfied by 22 patients (24.4%) of which 5 patients were defaulters. 32 patients (35.6%) of total study subjects didn’t get family support of them 6 were defaulters. The availability of the medicines in the DOTS centre felt oftenly available for 9 patients (10%) of the total study population. From the total study population, 9 (13.3%) of them visited daily, 31 (34.4%) of them visited weekly, 16 (17.8%) of them visited monthly and 22(24.4%) of them got medicines directly supplied to their homes by the government Asha workers or by the nurses. The details are summarized in the table 7 and table 8.

Table 8: Distribution of patients visits to occupy the medicines

Type of visit	Frequency (n= 90)	Percentage (%)
not visiting	12	13.3
daily	9	10.0
weekly	31	34.4
monthly	16	17.8
Supplied to home	22	24.4

Distribution of treatment assessment of non-interupted patients:

Out of the 69 patients continued the treatment without any interruptions, 21 patients (30.4%) were not satisfied with the treatment method, 24 patients (34.8%) felt no decrease in their symptoms, 20 patients (29.0%) did not evaluate their condition of their treatment undergoing and 13 patients (18.8%) missed their doses of the DOTS treatment. 39 patients (56.5%) of the total study population had no problems while taking the medicines. Weakness (17.4%) was the main problem while consuming the medications. The summarized details are listed in the table 9 and 10.

Table 9: distribution of treatment assessment.

Parameters		Frequency (n=69)	Percentage (%)
Satisfied With Treatment	Yes	48	69.6
Satisfied With Treatment	No	21	30.4
Decrease In Symptoms	yes	45	65.2
Decrease In Symptoms	No	24	34.8
Check-Up Or Evaluation	Yes	49	71.0
Check-Up Or Evaluation	No	20	29.0
Missed Doses	Yes	13	18.8
Missed Doses	No	56	81.2

Table 10: distribution of problems with the medications

Problems	Frequency (n=69)	Percentage (%)
No Problems	39	56.5
Body Pain	3	4.3
Weakness	12	17.4
Appetite Disturbance	3	4.3
Rashes	1	1.4
Stomach Pain	2	2.9
Joint Pain	2	2.9
Weakness + Loss Of Appetite	5	7.2
Sweating	2	2.9

Assessment of treatment defaulters in the study subjects.:

Among the 90 patients enrolled in the study, a total of 21 interruptions were found and out of which 12 were defaulters.

Distribution of time for treatment interruption:

From the study subjects, 4 patients (19.0%) each were interrupted from the first and second week respectively, 1 patient (4.8%) from the fourth week, 12 patients (57.1%) were found as defaulters. The details are summarized in the below table 11.

Table 11: Distribution of time for treatment interruption

Time of Interruption	Frequency (n=21)	Percentage (%)
1week	4	19.0
2 Week	4	19.0
4 Week	1	4.8
Default	12	57.1

Association of interuptions with the treatment phases:

Out of 21 patients, 8 (38.1%) of them interrupted during their intensive phase of which 5 (41.7%) were defaulters, 11 (52.4%) of them defaulted during there early continuation phase, of which 7(58.3%) were defaulters and 2 patients (9.5%) interrupted during their late continuation phase. No patients defaulted during their late continuation phase. The details are summarized in table 12.

Table 12: Association of interruptions with the treatment phases

Phase	With Default (n=12)	With Interruption (n=9)	Total (n=21)
Intensive Phase (0-2 months)	5 (41.7%)	3 (33.3%)	8 (38.1%)
Early Continuation Phase (2-4months)	7 (58.3%)	4(44.4%)	11 (52.4%)
Late Continuation Phase (>4 months)	-	2 (22.2%)	2 (9.5%)

Distribution of resons for defaulting the treatment.:

From the defaulters, 5 patients (41.7%) defaulted due to the belief that they have been felt well with the tuberculosis treatment, 3 patients (25.0%) defaulted due to side effects. 1 patient (8.3%) each defaulted due to migration, non-availability of medicines, transport problems. The details are listed in the table 13.

Table 13: Distribution of reasons for defaulting the treatment

Reasons	Frequency (n=12)	Percentage (%)
Side effects	3	25.0
Felt well with TB treatment	5	41.7
Migration	1	8.3
Non-availability of medications in DOTS centre	1	8.3
Health centre was far /could not afford the transport charges	1	8.3
Others	1	8.3

Distribution of resons for interupting the treatment method.:

Out of 9 interruptions, 3 (33.3%) of them interrupted due to workload, 2 of them interrupted due to migration. The details of the distribution of reasons for interrupting the treatment method are summarized in the below table 14.

Table14: Distribution of reasons for interrupting the treatment method

Reasons	Frequency (n=9)	Percentage (%)
Workload	3	33.3
Migration	2	22.2
Not willing to take medicines	1	11.1
Attending Function	1	11.1
Did not felt well with treatment	1	11.1
Others	1	11.1

DISCUSSION:

Tuberculosis is still continuing as one of the top 10 major causes of death in the world. Adherence to the DOTS treatment is must for the smooth completion of therapy. Prolonged treatment duration, dosage forms, stigma problems of the patients, lifestyle problems still remain as a major task for the patients in completing the treatment. This in turn leads to the treatment interruption, relapse and medication-resistant. The study was set up to explore the defaulting nature of the tuberculosis patients in a tertiary care teaching hospital, which will enable to gather valuable information to improve the effectiveness of the DOTS treatment in the current scenario.The case fatality rate (CFR) of the study was found to be 4.4. In our country the CFR varies from 10-19. This study showed a lesser CFR, which is the approximate value to be reached in the milestones of End TB strategy 2025.¹

The present study evaluated the condition of patients defaulting the DOTS therapy. The incidence of default from the DOTS therapy in our hospital during the study period was found to be 13.3 %. Studies carried out by Pandit N et al¹⁰, Gelmanova IY et al¹¹, Gortiyala S B et al² reported that comparable incidence of defaulters were present which ranged from 7.35% to 19.83%. A study conducted by Al-Hajjaj MS et al¹²was in correspondence with the present study in which the default rate was 13%. A study done by Muture BN et al¹³ showed the default rate of 47.8% which is more than 3 times of the result seen in the present study. The reason for this variation may be due to status of the patients, hospital settings, education and knowledge of both treatment and disease. Apart from these, the study of population, regimen followed in the state, methodology used to identify the defaulters may affect significant changes in the incidence of the default rate.²

In the present study, males (66.7%) had the highest incidence of the default rate compared to that of females. Almost all the studies done by Pandit N et al¹⁰, Buu TN et al¹⁴, Gelmanova IY et al¹¹, Slama k et al¹⁵ had similar results. Thus, majority of the studies showed male population was highest in the prevalence of defaulting patients to the treatment, which concluded that males are to be a key risk factor for the default. Work load and family support were the main reasons for the males in misleading to the treatment approach.¹³ But the study done by Al-Hajjaj MS et al¹² noted the difficulty of female patients to acquire the treatment strategy will be a strong task for them. The reasons stated by them were dependence on male partners, acquisition of transport facility, emotional and physical problems. The study also suggests measures are to be undertaken to help the female patients as well as to educate the male patients.

Regarding the age wise categorization of the study subjects, patients aged more than 50 years had the highest defaulting rate. This was in contrast to the studies conducted by Gelmanova IY et al¹¹, Balabanova Y et al¹⁶, Muture BN et al¹³as the mean age of these studies were found to be 40 years, 38.5 years, 31.2 years respectively. These studies reported less incidence of default in people aged > 60 years of age. A study conducted by Amoran OE et al¹⁷ exhibited that the mean age to default was between 16 to 30 years of age, which became nearly the opposite to the present study results. The factors for default in the age group above 50 years was of less knowledge of the patients and having less family support to the treatment.

In the present study, patients from rural areas and patients pursuing primary education were more keen to defaulting. Pandit N et al¹⁰ supported these findings through similar study results. The educational status for defaulting varied to have more in the illiterate patients in some studies^2,18,19. This was due to the variation in the study settings. Regarding the social habits alcoholics were found as a major risk factor for patients to forbid the treatment process in many studies^20,10,15,18. But in the present study there were only 4 among 22 patients defaulted who had social habits. Therefore, in the current study the social habits did not have similar effect in defaulting the treatment.

In the present study, PTB had higher chances of getting defaulted than the EPTB. This was supported by Chee CB et al¹⁹, Tekle B et al²¹, Balabanova Y et al¹⁶, Muture BN et al¹³, in which the pulmonary cases had more chances to default because their symptoms get reduced easily on or within the completion of continuation phase or before. There were no significant characteristics of comorbidities affecting the defaulters in the present study. The studies conducted by Daniel OJ et al²³, Kruyt ML et al²⁴was contradictory to the present study where there was a drastic importance to comorbidities in defaulting. HIV infection were more burden in these studies. But in the present study out of 23 diabetes mellitus patients, 4 of them were defaulters which concluded that having multiple disease along with tuberculosis can result in uncontrollable management of the conditions.¹⁶

In the present study, early continuation phase (2 to 4 moths) had higher chances of defaulting than others. The mean time to default in the present study was 9.7 weeks. A review work done by Kruk ME et al²⁴on the time period of default from the tuberculosis treatment supported with multiple results reviewed, among which they concluded that patients stigma towards treatment was directly proportional to the timing of the default. The mean time to default the treatment from the studies ranged from 6.0 weeks to 13.6 weeks. The patients found easy to complete the first phase of the treatment and found difficulty in completing the next phase.²⁴

From the total defaulters to the treatment in the study 41.7% were defaulted since they felt well and observed a decline in their symptoms. Similar results were exhibited by the study done by Gortiyala S B et al^2. Studies done by Jaggarajamma K et al²⁰, Sanchez-Padilla E et al²⁵ also had the reason listed as one of the major factor for defaulting. As challenging to the treatment, majority of the studies showed the main reasons for the defaulter was the toxicity of the drugs^14,10,20. DOTS is a multi-drug regimen, chances of toxicity is much greater than other forms of treatment. Jaiswal A et al²⁶ suggested that the importance of ADR monitoring and detection as a practical measure to smoothen the treatment. The present study proved that there was an improvement in the therapy besides to the side effects initiated by it. Out of 17 patients with ADRs only 2 of them defaulted. After their default, both patients took private medications in change to the DOTS therapy for their disease management. This was enhanced by the healthcare professionals of the hospital settings by managing the side effects, increasing length of hospital stay till the patient adapted the therapy and continuous reviewing and evaluating the patients disease status. This follow-up by the medical professionals made the treatment success and stepped towards decreasing the default rate in the hospital.

In the present study, the other reasons mentioned by the patients were migration, transport charges, workload, medical issues, non-availability of medicines, family problems and ignorance to medications. These small issues are to be considered as the major one because patients are defaulting to these reasons. Similar findings were found by Kruyt ML et al²³, Castelnuovo B et al²⁷, OboyleS et al²⁸suggested an improvement for this small issues.

In the present study small distance to the treatment centers, no difficulty in procuring medicines, good behavior of DOTS providers, family support, delivering of medicines by government workers or weekly visit to treatment centers improved the treatment method. Periodical evaluation of the disease state, satisfaction with the treatment method, decrease in symptoms with drug intake, not missing doses and not having problem with the medication also enhanced the treatment success according to the study findings. Similar strategies was supported by the study conducted by Sagbakken M et al²⁹for improving the treatment measures.

CONCLUSION:

The present study clearly showed the incidence of defaulters from the tuberculosis patients receiving DOTS therapy. Patients felt well with the treatment were more among the defaulters than the other patients who defaulted. Side effects due to drugs, workload, migration, family problems were the other reasons mentioned by the patients who defaulted the treatment. The overall default rate was completely less in the study because of the complete involvement of the health professionals in the system of the treatment. Education and regular contact with the patients was found as the key to success in completing the treatment. The study results provide an insight to the health care providers on the importance of patient counselling, monitoring and evaluating disease conditions periodically of patients who are keen to defaulting. This can be enhanced by the clinical pharmacists in promoting the DOTS therapy to improve the patients adherence towards it by providing patient counselling, there by achieving a well treatment outcome

ACKNOWLEDGEMENT:

The authors are grateful to the authorities of NITTE (Deemed to be University), Justice K S Hegde Hospital, NGSM Institute of Pharmaceutical sciences, Mangaluru for providing all the facilities.

CONFLICT OF INTEREST:

The authors declare no conflict of interest.

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Received on 09.01.2019 Modified on 08.02.2019

Research J. Pharm. and Tech. 2019; 12(5):2245-2253.

DOI: 10.5958/0974-360X.2019.00374.3

Parameters		With Defaulters (n=12)	Without Defaulters(n=78)	Total (n=90)
Distance	0-2kms	1 (8.3%)	32(41.0%)	33(36.7%)
	<5kms	4 (33.3%)	24 (30.8%)	28(31.1%)
	<10kms	5 (41.7)	17 (21.8%)	22(24.4%)
	>10kms	2 (16.7%)	5 (6.4%)	7(7.8%)
Problems Faced To Get Medicine	Transport	3(25.0%)	14 (17.9%)	17(18.9%)
	Staying Alone	2(16.7%)	8 (10.3%)	10 (11.1%)
	Time	-	8 (10.3%)	8(8.9%)
	Workload	3(25.0%)	6 (7.7%)	9 (10 %)
	No Problems	4(33.3%)	42 (53.8%)	46 (51.1%)
Satisfaction With DOTS Providers Attitude	Satisfied	7 (58.3%)	61 (78.2%)	68 (75.6%)
Satisfaction With DOTS Providers Attitude	Dissatisfied	5 (41.7%)	17 (21.8%)	22 (24.4%)
Family Support	Yes	6 (50.0%)	52 (66.7%)	58 (64.4%)
Family Support	No	6 (50.0%)	26 (33.3)	32 (35.6%)
Availability of Medicines	Always	9 (75.0%)	72 (92.3%)	81 (90.0%)
Availability of Medicines	Sometimes	3 (25.0%)	6 (7.7%)	9 (10.0%)