Prospective, open-label study to validate proper use of the Versacloz™ (clozapine) oral suspension kit by people with schizophrenia

Figures & data

Table 1 Number of prepared doses

User group	First dose, n	Second dose, n
Untrained	46 (unaided)	46 (unaided)
Trained	15 (supervised)	15 (unaided)
Total	107 (unaided)	107 (unaided)

Table 2 User failure mode and effects analysis

Preparation task	Risk	Clinical impact
Shake bottle for 10 seconds to mix medicine	Medium	Clinically significant under- or overdose
Remove bottle cap	Low	Inability to remove cap and prepare dose
Insert bottleneck adaptor	Medium	Inability to prepare dose; spillage and contamination of medication
Select oral dosing syringe	Medium	Clinically significant under- or overdose
Fill oral dosing syringe with air	Low	Clinically significant under- or overdose
Insert oral dosing syringe tip into bottleneck adaptor	Low	Spillage and contamination of medication
Draw medicine into the oral dosing syringe	High	Clinically significant under- or overdose
Remove air from the oral dosing syringe	Low	Clinically significant underdose
Remove oral dosing syringe from bottleneck adaptor	Low	n/a
Insert tip of oral dosing syringe into mouth and close lips	Medium	Clinically significant underdose
Push plunger to expel medicine into mouth and swallow	Medium	Clinically significant underdose
Replace bottle cap	Medium	Spillage and contamination of medication
Rinse oral dosing syringe with warm water	Low	Contamination of oral dosing syringe or medication
Storage of kit components	High	Contamination or degradation of medicine

Abbreviation: N/A, not applicable.

Table 3 Participant demographics

Characteristic	Total (N=61)	Trained group (n=15)	Untrained group (n=46)	P-value^a
Age (years)				0.056
Mean (SD)	40.6 (11.28)	45.5 (10.74)	39.1 (11.12)
Median	41.0	50.0	38.0
Range (minimum, maximum)	(20, 62)	(24, 61)	(20, 62)
Sex, n (%)				0.833
Male	42 (68.9)	10 (66.7)	32 (69.6)
Female	19 (31.1)	5 (33.3)	14 (30.4)
Race/ethnicity, n (%)				0.134
White	31 (50.8)	9 (60.0)	22 (47.8)
Black	9 (14.8)	4 (26.7)	5 (10.9)
Hispanic	9 (14.8)	1 (6.7)	8 (17.4)
Asian	7 (11.5)	0	7 (15.2)
Native American	3 (4.9)	0	3 (6.5)
Pacific Islander	1 (1.6)	0	1 (2.2)
Other	1 (1.6)	1 (6.7)	0
Current treatment, n (%)				0.506
Stabilized on clozapine^b	28 (45.9)	8 (53.3)	20 (43.5)
Stabilized on another drug	33 (54.1)	7 (46.7)	26 (56.5)
Risperidone	13 (21.3)	5 (33.3)	8 (17.4)
Quetiapine	12 (19.7)	4 (26.7)	8 (17.4)
Aripiprazole	11 (18.0)	3 (20.0)	8 (17.4)
Olanzapine	6 (9.8)	3 (20.0)	3 (6.5)
Divalproex	2 (3.3)	0	2 (4.3)
Ziprasidone	2 (3.3)	1 (6.7)	1 (2.2)
Hydroxyzine	1 (1.6)	0	1 (2.2)
Paliperidone	1 (1.6)	0	1 (2.2)
Haloperidol	1 (1.6)	0	1 (2.2)
Lurasidone	1 (1.6)	0	1 (2.2)

Notes:

a P-value is from two-sample t-test for numeric data and chi-square for categorical data;

b alone or in combination with other antipsychotic medications.

Abbreviation: SD, standard deviation.

Table 4 Dose assignments

Assigned dose	Untrained group, n (%) (n=46)	Trained group, n (%) (n=15)
1 ml	15 (32.6)	5 (33.3)
3.5 mL	16 (34.8)	5 (33.3)
5 mL	15 (32.6)	5 (33.3)

Table 5 Summary of errors by risk level in trained participants

Observation/measure	Risk level	Dose 1, n (%) (n=15)
Overall failure rate	–	0 (0)
Participant uses IFU	–	14 (93.3)
Failure to replace cap	Medium	1 (6.7)
Failure to fill dosing syringe with air	Low	1 (6.7)

Abbreviation: IFU, instructions for use.

Table 6 Summary of failures and most common errors (≥10% for either dose) by risk level in untrained participants

Observation/measure	Risk level	Dose 1, n (%) (n=46)	Dose 2, n (%) (n=46)	Overall, n (%) (n=92)
Overall failure rate	–	3 (6.5)	10 (21.7)	13 (14.1)
Participant uses IFU	–	40 (87.0)	38 (82.6)	78 (84.8)
Failure to obtain correct dose	High	2 (4.3)	6 (13.0)	8 (8.7)
Failure to insert bottleneck adaptor	Medium	15 (32.6)	1 (ll.l)^a	16 (29.l)^b
Did not attach bottleneck adaptor	Medium	8 (17.4)	0 (0)^a	8 (l4.5)^b
Partially attached bottleneck adaptor	Medium	7 (15.2)	1 (ll.l)^a	8 (l4.5)^b
Failure to fill dosing syringe with air	Low	22 (47.8)	16 (34.8)	38 (41.3)
Failure to remove air from dosing syringe	Low	17 (37.0)	13 (28.3)	30 (32.6)

Notes:

a Nine evaluable samples;

b fifty-five evaluable samples.

Abbreviation: IFU, instructions for use.