A cross- sectional study was conducted in a community-pharmacy set up with 206 participants using a validated questionnaire, of which 198 subject data was included for the study based on the inclusion and exclusion criteria and sample size calculated.
Questionnaire validation
Data from an initial sample (n=22) was captured and assessed for their internal consistency and reproducibility using Cronbach’s alpha and intra class correlation coefficient (ICC) respectively. Cronbach’s alpha is measure of how closely related a set of items are as a group. As the average inter-item correlation increases, Cronbach’s alpha also increases. A value of 0.8 and above is considered acceptable. ICC is a measure of how strongly the items in a group resemble each other. ICC value of 0.75 and above is considered good, and above 0.9 is excellent. Cronbach’s alpha and ICC values was calculated for the 10 items in the domain with sample size of 22 subjects (Table 1). Cronbach’s value and ICC was 0.92 and 0.85 respectively. Internal consistency of each item in the questionnaire is given (Fig. 1).
Table 1 Mean score, Cronbach’s alpha, and Intra-class correlation coefficient of knowledge section
Sl. No.
|
Items
|
Cronbach’s alpha coefficient (n=22)
|
Intra-class correlation coefficient (n=22)
|
Q1
|
Describe your relationship with the patient.
|
0.98
|
0.94
|
Q2
|
Since how long has the patient been taking this medication (years)
|
0.98
|
0.96
|
Q3
|
Do you know the name of the psychotropic medication which the patient is being administered?
|
0.97
|
0.86
|
Q4
|
If yes, pick the psychotropic medication which the patient is administering.
|
0.94
|
0.85
|
Q5
|
Has the patient experienced any kind of respiratory illness following the use of psychotropic medication?
|
0.97
|
0.95
|
Q6
|
If yes, what kind of a respiratory illness?
|
0.95
|
0.92
|
Q7
|
Describe the type of respiratory illness.
|
0.88
|
0.94
|
Q8
|
Does the patient have any co-morbidities?
|
0.90
|
0.84
|
Q9
|
If yes, which co-morbid condition does the patient have?
|
0.92
|
0.86
|
Q10
|
Has the patient tested COVID-19 positive during the course of psychotropic therapy?
|
0.85
|
0.91
|
Distribution of age, gender and relationship with the patient was analyzed and reported for all the subjects (n=198) (Table 2). Among 198 patients, majority were male [127 (64.14)]. Majority of the respondents were from the age group >60years [124 (62.3)]. The patient himself/ herself were major part of the respondents of the study [137 (69.19)].
Table 2 Demographics
Sl.No
|
Parameter
|
Category
|
Number (%)
|
1
|
Age (Years)
|
19-40
41-60
>60
|
51 (25.76)
23 (11.62)
124 (62.63)
|
2
|
Gender
|
Male
Female
Other
|
127 (64.14)
67 (33.84)
4 (2.02)
|
3
|
Relationship with the patient
|
Patient himself/herself
First degree relative
Grandparents
Spouse
|
137 (69.19)
53 (26.77)
6 (3.04)
2 (1.01)
|
Distribution of the duration of psychotropic therapy
The study showed that majority of the subjects had a psychotropic drug use duration lesser than a year 145 (73.23), followed by a duration of 1-5 years 48 (24.24) and 5-10years 3 (1.52) (Fig. 2)
Distribution of the psychotropic drug class used
Among the psychotropic drugs used, benzodiazepines were most commonly used 85 (35.75), followed by antipsychotics 39 (19.7) of which 33 (84.61) were SGA users and 6 (15.4) were FGA users, SSRI users 33 (16.17), mood stabilizers users 8 (4.04) and SNRI users 5 (2.53) (Fig.3).
Distribution of incidence of respiratory disorders in subjects during the course of psychotropic drug therapy
Of 198 patients under study, 95(47.98) experienced respiratory disorders during the course of the therapy, however 97(48.99) did not report any respiratory illness (Fig. 4).
Distribution of type of respiratory disorder during the course of psychotropic drug therapy
It was observed that 59 (29.8) of 198 participants experienced respiratory infection, 33 (16.16) experienced breathing difficulty and 4 (2.02) experienced pneumonia during the course of psychotropic drug therapy (Fig. 5).
Distribution of the kind of respiratory illness during the course of psychotropic drug therapy
Majority of the population reported a respiratory illness which resolved itself without treatment 55 (27.78%), 24 (12.12%) had a respiratory illness which subsided on treatment, 17 (8.59%) reported respiratory illness which did not get better with treatment (Fig. 6).
Distribution of comorbid conditions in patient population
79 (39.9) of the participants had comorbid condition out of a total of 198 participants (Fig. 7). Majority of the population had hypertension 29 (14.69), followed by Diabetes mellitus in 26 (13.13) participants, asthma in 11 (5.56) participants, Epilepsy in 5 (2.53), Diabetes and hypertension in 5 (2.53), Ischemic Heart Disease in 3 (1.52) and Diabetes and Ischemic Heart Disease in 1 (0.52) participants (Fig. 8).
Distribution of number of patients COVID positive during the course of psychotropic drug therapy
Of the total population of 198 patients exposed to psychotropic drug therapy, 23 (11.62) patients were tested COVID positive during the course of the therapy. However, 173 (87.37) were not tested positive (Fig. 9).
Association between Individual Drug Class Usage and Risk of Respiratory Disorder
All the captured data was statistically analyzed and the association was expressed as Odds ratio. Statistically significant association was observed between benzodiazepine (OR 1.46, 95% CI 0.81-2.64, P value 0.2) (Fig. 10), antipsychotics (OR 1.97, 95% CI 0.81-2.64, P value<0.05) (Fig. 11) use and risk of respiratory disorders. SGA was associated with increased risk of respiratory disorder compared to FGA (OR 0.23, 95% CI 0.07-0.77, P value <0.05) (Fig. 12). SSRI/SNRI (OR – 0.59 [0.24-1.4], P Value <0.05) was associated with decreased risk of respiratory disorder compared to other psychotropic drug use (Fig. 13).