Magnitude, Nature, and Risk Factors of Adverse Drug Reactions Associated with First Generation Antipsychotics in Outpatients with Schizophrenia: A Cross-Sectional Study

Figures & data

Table 1 Demographic Characteristics of the Study Participants (n=242)

Characteristics		Frequency	Percent
Gender
	Male	138	57
	Female	104	43
Religion
	Christian	205	84.7
	Moslem	37	15.3
Education
	Primary/no formal education	38	15.7
	Middle	54	22.3
	Secondary	113	46.7
	Higher	37	15.3
Employment
	Employed	73	30.2
	Unemployed	169	69.8
Marital status
	Single	110	45.5
	Married	98	40.5
	Divorced	20	8.3
	Separated	7	2.9
	Widowed	7	2.9
Residence
	Asmara	162	66.9
	Outside Asmara	80	33.1
Smoking
	Yes	48	19.8
	No	194	80.2
Alcohol
	Yes	25	10.3
	No	217	89.7
Characteristics	Min, Max	Mean, SD	Median, IQR
Age (years)	18, 70	39.73, 11.22	39.00, 16.00
Weight (kg)	35, 100	61.47, 11.56	60.00, 17.00

Abbreviations: SD, standard deviation; IQR, inter quartile range; Min, minimum; Max, maximum; n, number of participants.

Table 2 Clinical Variables of the Study Participants (n=242)

Characteristics		Frequency	Percent
Antipsychotic medications^a
	Chlorpromazine oral tablet	167	69
	Haloperidol oral tablet	37	15.3
	Fluphenazine decanoate depot	164	67
Other medications used		14	5.7
	Promethazine	10	4.1
	Trihexyphenidyl	2	0.8
	Diazepam	2	0.8
Number of antipsychotics
	Single	123	50.83
	Multiple	119	49.17
Counseling on ADRs
	Yes	122	50.4
	No	120	49.6
Insight
	Poor insight	53	21.9
	Partial insight	60	24.8
	Good insight	129	53.3
Characteristics	Min, Max	Mean, SD	Median, IQR
Duration of illness (months)	3, 651	157.90, 112.44	147, 75
Antipsychotic dose (mg/day, chlorpromazine equivalents)	48.08, 792.31	244.64, 147.61	196.15, 200

Note: ^aParticipants can select more than one response.

Abbreviations: IQR, inter quartile range; SD, standard deviation; Min, minimum; Max, maximum; n, number of participant.

Table 3 Categories of Total ADR Score in the Sample Population

Total ADR Score Category	Percent
Very high (101–164)	0
High (81–100)	1.65
Medium (41–80)	22.73
Low (0–40)	75.62

Table 4 Prevalence, Total ADR Score and Nature of ADRs

Variables	Prevalence	Total ADR Score
	n (%)	M (SD)	Actual Range	Expected Range
ADRs of antipsychotics	227 (93.8)	28.01 (18.46)	0–92	0–164
Psychic ADRs	221 (91.3)	11.00 (7.30)	0–33	0–40
Tiredness	152 (62.8)	1.36 (1.28)	0–4	0–4
Tension	145 (59.9)	1.2 (1.26)	0–4	0–4
Depression	143 (59.1)	1.13 (1.19)	0–4	0–4
Difficulty getting to sleep	137 (56.6)	1.2 (1.26)	0–4	0–4
Difficulty staying awake during the day	135 (55.8)	1.26 (1.37)	0–4	0–4
Sleeping too much	133 (55)	1.26 (1.36)	0–4	0–4
Difficulty in concentrating	118 (48.8)	1.07 (1.30)	0–4	0–4
Difficulty in remembering things	107 (44.2)	0.88 (1.16)	0–4	0–4
Increased dreaming	106 (43.8)	0.94 (1.27)	0–4	0–4
Lack of emotions	88 (36.4)	0.7 (1.10)	0–4	0–4
Autonomic ADRs	189 (78.1)	2.99 (2.76)	0–13	0–20
Feeling sick	129 (53.3)	1.01 (1.17)	0–4	0–4
Dizziness	106 (43.8)	0.84 (1.11)	0–4	0–4
Increased sweating	70 (28.9)	0.5 (0.92)	0–4	0–4
Palpitations	64 (26.4)	0.4 (0.77)	0–4	0–4
Diarrhea	35 (14.5)	0.24 (0.64)	0–4	0–4
Extrapyramidal ADRs	186 (76.9)	4.45 (4.52)	0–20	0–28
Restlessness	140 (57.9)	1.15 (1.20)	0–4	0–4
Muscle stiffness	90 (37.2)	0.74 (1.10)	0–4	0–4
Parts of body moving on their own	73 (30.2)	0.64 (1.12)	0–4	0–4
Shakiness	68 (28.1)	0.64 (1.12)	0–4	0–4
Slowing of movements	66 (27.3)	0.57 (1.01)	0–4	0–4
Muscle spasms	41 (16.9)	0.39 (0.98)	0–4	0–4
Over-wet or drooling mouth	41 (16.9)	0.33 (0.79)	0–4	0–4
Miscellaneous	161 (66.5)	2.21 (2.24)	0–10	0–16
Headaches	100 (41.3)	0.79 (1.10)	0–4	0–4
Putting on weight	80 (33.1)	0.69 (1.11)	0–4	0–4
Losing weight	55 (22.7)	0.45 (0.96)	0–4	0–4
Pins and needles	36 (14.9)	0.28 (0.74)	0–4	0–4
Hormonal ADRs	141 (58.3)	2.28 (2.60)	0–11	0–24
Reduced sex drive	87 (36)	0.79 (1.19)	0–4	0–4
Difficulty achieving climax	68 (28.1)	0.60 (1.09)	0–4	0–4
Increased sex drive	40 (16.5)	0.28 (0.74)	0–4	0–4
Period problems	34 (14)	0.32 (0.87)	0–4	0–4
Periods less frequent	26 (10.7)	0.23 (0.72)	0–4	0–4
Swollen or tender chest	9 (3.7)	0.07 (0.42)	0–4	0–4
Anticholinergic ADRs	107 (44.2)	3.42 (3.22)	0–13	0–20
Blurred vision	100 (41.3)	0.75 (1.06)	0–4	0–4
Passing a lot of water	99 (40.9)	0.94 (1.31)	0–4	0–4
Constipation	84 (34.7)	0.71 (1.11)	0–4	0–4
Dry mouth	78 (32.2)	0.6 (0.99)	0–4	0–4
Difficulty passing water	46 (19)	0.41 (0.94)	0–4	0–4
Allergic ADRs	107(44.2)	1.65 (2.61)	0–13	0–16
Sensitivity to sun (photosensitivity)	80 (33.1)	0.79 (1.24)	0–4	0–4
Itchy skin	46 (19)	0.38 (0.92)	0–4	0–4
Rash	30 (12.4)	0.25 (0.75)	0–4	0–4
New or unusual skin marks	24 (9.9)	0.23 (0.76)	0–4	0–4
Red herrings	107 (44.2)	1.78 (3.04)	0–18	0–40

Abbreviations: M, mean; n, number; SD, standard deviation; %, percent.

Table 5 Independent Sample t-Test of the Mean Score of ADRs Among Various Categories of the Demographic and Clinical Variables

Variables		M (SD)	MD	95% CI	P-value
Gender
	Male	31.04 (18.72)	7.04	2.39–11.68	0.003
	Female	24.00 (17.39)
Smoking status
	Yes	35.92 (18.57)	9.86	4.12–15.60	0.001
	No	26.06 (17.99)
Alcohol consumption
	Yes	34.36 (16.85)	7.08	−0.56–14.72	0.069
	No	27.28 (18.53)
ADRS-counseling
	Yes	29.77 (2.16)	3.55	−1.11–8.20	0.135
	No	26.22 (16.45)
Employment
	Unemployed	27.49 (16.75)	2.59	−7.43–3.98	0.550
	Employed	29.22 (29.99)
Number of antipsychotics
	Single	25.30 (19.31)	−5.51	−10.15–-0.88	0.020
	≥2	30.81 (17.17)

Abbreviations: M, mean; MD, mean difference; CI, confidence interval.

Table 6 ANOVA of the Mean Score of ADRs Among Various Categories of Educational Level

Variables		M (SD)	P-value	P-trend
Educational Level
	Primary/no formal education	21.21 (13.33)	0.018	0.004
	Middle	25.07 (16.74)
	Secondary	30.90 (20.72)
	Higher	30.46 (16.00)
Insight
	Poor insight	26.15 (14.49)	0.693	-
	Partial insight	28.97 (14.56)
	Good insight	28.33 (21.37)

Abbreviations: M, mean; SD, standard deviation; PO, per Os; IM, intramuscular.

Table 7 Post Hoc LSD Analysis of the Mean Score of ADRs Among Various Categories of Educational Level

Variables		MD (95% CI)	P-value
Educational level
	Middle, primary/no formal education	3.86 (−3.72–11.45)	0.317
	Secondary, primary/no formal education	9.69 (2.97–16.41)	0.005
	Higher, primary/no formal education	9.25 (0.97–17.52)	0.029
	Secondary, middle	5.83 (−0.99–1176)	0.054
	Higher, middle	5.38 (−2.26–13.03)	0.167
	Higher, secondary	0.44 (−7.23–6.34)	0.898

Abbreviations: MD, mean difference; PO, per Os; IM, intramuscular.

Table 8 Pearson’s Correlation of Demographic as Well as Clinical Variables and ADR Score

Variables	r, n	P
Age	0.056, 242	0.382
Weight	0.052, 242	0.423
Duration of illness	−0.140, 242	0.030
Dose	0.174, 242	0.007

Abbreviation: r, Pearson’s correlation coefficient.

Table 9 Socio-Demographic and Clinical Predictors of LUNSERS Score Using Two-Step Hierarchical Multiple Regression Model

	Predictors	b (95% CI)	SE (B)	β	P-value
Step 1	Intercept	16.09 (9.54–22.64)	3.32		<0.001
	Gender^a	2.94 (−2.16–8.04)	2.59	0.08	0.258
	Smoking^b	7.78 (1.62–13.95)	3.13	0.17	0.014
	Education – Middle^c	1.04 (−6.46–8.53)	3.80	0.02	0.785
	Education – Secondary^d	7.67 (0.99–14.34)	3.39	0.21	0.025
	Education – Higher^e	5.35 (−3.06–13.77)	4.27	0.11	0.211
	Antipsychotic dose	0.02 (0.00–0.03)	0.01	0.13	0.035
Step 2
	Intercept	13.62 (6.43–20.81)	3.65		<0.001
	Gender^a	2.69 (−2.41–7.79)	2.59	0.07	0.300
	Smoking^b	7.00 (0.76–13.25)	3.17	0.15	0.028
	Education – Middle^c	1.57 (−5.94–9.07)	3.81	0.04	0.681
	Education – Secondary^d	8.36 (1.65–15.07)	3.41	0.23	0.015
	Education – Higher^e	5.96 (−2.47–14.39)	4.28	0.12	0.165
	Antipsychotic dose	0.01 (−0.01–0.03)	0.01	0.09	0.269
	Number of Antipsychotics^f	1.60 (−4.32–7.51)	3.00	0.04	0.569
	Duration of illness	0.02 (−0.00–0.04)	0.01	0.11	0.094

Notes: b (95% CI), unstandardized coefficient and the corresponding 95% CI; SE (B), standard error of the coefficient; β, standardized coefficient. R²=0.086 for step 1, Δ R²=0.011 for step 2. Dummy coding: ^aCoded female=0, male=1; ^bCoded no=0, yes=1; ^cCoded middle=1, otherwise=0; ^dCoded secondary=1, otherwise=0; ^eCoded higher=1, otherwise=0; ^fCoded 0=single, 1=multiple.

Table 10 Prevalence of ADRs Reported Among Different Studies Using LUNSERS and Types of Antipsychotics Used

Studies and Number of Study Respondents	ADRs Prevalence (%)	Antipsychotic Drugs Used
		FGAs (%)	SGAs (%)	FGAs and SGAs Combined (%)
Current study (Eritrea), n=242	93.8	100	0	0
Australia,^Citation29 n=100	100	60	40	0
Singapore,^Citation8 n=96	89.6	25	70.8	4.2
Australia,^Citation30 n=81	50	4.9	86.4	8.6

Abbreviation: n, number of study respondents.

Morrison P, Gaskill D, Meehan T, Lunney P, Lawrence G, Collings P. The use of the Liverpool University neuroleptic side‐effect rating scale (LUNSERS) in clinical practice. Aust N Z J Mental Health Nurs. 2000;9(4):166–176. doi:10.1046/j.1440-0979.2000.00181.x

 Google Scholar

Chiang YL, Klainin‐Yobas P, Ignacio J, Chng CML. The impact of antipsychotic side effects on attitudes towards medication in people with schizophrenia and related disorders. J Clin Nurs. 2011;20(15–16):2172–2182. doi:10.1111/j.1365-2702.2010.03659.x21539628

 PubMed Web of Science ®Google Scholar

McCann TV, Clark E, Lu S. Subjective side effects of antipsychotics and medication adherence in people with schizophrenia. J Adv Nurs. 2009;65(3):534–543. doi:10.1111/j.1365-2648.2008.04906.x19222651

 PubMed Web of Science ®Google Scholar