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PHARMACOEPIDEMIOLOGICAL
MONITORING HELPS IN
REDUCING OF NEUROLEPTICINDUCED EXTRAPYRAMIDAL
DISORDERS AT THE
PSYCHIATRIC CLINICAL
HOSPITAL OF THE REPUBLIC
OF TATARSTAN
Ziganshina LE, Kuchaeva AV, Gatin FF, Minnetdinova LM
Kazan State Medical Academy and Republican Clinical Psychiatric
Hospital — Russia
Pharmacoepidemiological Monitoring Helps in Reducing Neuroleptic-Induced Extrapyramidal
Disorders at the Psychiatric Clinical Hospital in Tatarstan
Ziganshina LE, Kuchaeva AV, Gatin FF, Minnetdinova LM
Kazan State Medical Academy and Republican Clinical Psychiatric Hospital, Russia
Problem Statement: Extrapyramidal movement disorders caused by neuroleptics are easily diagnosed;
however, the prognosis of their development and the severity of presentation remains obscure. Polypharmacy
and drug interactions contribute to the complexity of the problem.
Objectives: To evaluate the effect of pharmacoepidemiological monitoring of the use of neuroleptics on
prescription habits of psychiatrists using the World Health Organization (WHO) drug use indicators.
Design: Drug use indicator study.
Setting and Population: Special sheets for registering the side effects of neuroleptics were developed and
included in regular medical charts in 2000–2002. The case records of 666 patients with schizophrenia in whom
extrapyramidal reactions were registered were randomly chosen for statistical analysis. Total daily doses of
neuroleptics were calculated with the help of chlorpromazine equivalent, and ATC classification was used for
analysis.
Intervention: The initial drug use indicator study was carried out in 2001. The dosage of neuroleptics and
monitoring of drug safety and interactions were implemented for the two-year period (2001–2002). The
subsequent drug use study was performed in 2002.
Outcome Measures: Total daily doses of neuroleptics (in terms of oral chlorpromazine and defined daily
doses), the WHO drug use indicators.
Results:The total daily dose of neuroleptics in patients with paranoid schizophrenia with hallucinativeparanoidal syndrome in 2000 was 3,053 ±116 mg of oral chlorpromazine. In cases of paranoid schizophrenia
with prevalent paranoid syndrome, the total neuroleptic load was lower at 2,547 ±107 mg. In patients with a
history of cerebral-organic deficiency, the total neuroleptic load was 1,653 ±123 mg. The number of medicines
prescribed per case (indicator 1) was 8.3 ±0.5 in 2001. After introduction of the active monitoring system, it
decreased to 5.8 ±0.6 medicines per case in 2002. The percentage of generic medicines prescribed (indicator 2)
was 56.7% in 2001 and 69.1% in 2002. The percentage of cases with antibiotics prescribed (indicator 3) was
32.2% in 2001 and 10.6% in 2002. The frequency of injection use (indicator 4) was 40.8% in 2001 and 38.8%
in 2002. The percentage of medicines prescribed from the formulary list (indicator 5) was only 63.5% in 2001
but had risen to 99% in 2002.
Conclusions: The introduction of a pharmacoepidemiological monitoring system in a psychiatric clinical hospital
proved effective in reducing polypharmacy, injection and antibiotic use, and the total neuroleptic load and
adverse effects profile in schizophrenia patients.
Background/Introduction
Psychotropic medicines allow to control the
symptoms of schizophrenia. The prognosis of
schizophrenia depends on the adequate and
timely anti-psychotic therapy which is
necessary for prevention of irreversible
personality changes of the patients. One of the
major problems of psychopharmacotherapy of
schizophrenic patients is the problem of sideeffects.
Objectives:
To evaluate the effect of
pharmacoepidemiological monitoring
on the use of neuroleptics
on prescription habits of psychiatrists
using the World Health Organization
(WHO) drug use indicators.
Methods
Clinical Psychiatric Hospital of the Ministry of Health of
the Republic of Tatarstan (>2000 beds)
7475 side effects registration cards - 2000, 2001, 2002
Chlorpromazine equivalents for calculation of the total
neuroleptics’ daily doses
ATC-DDD methodology.
Subgroup analysis: age, gender, length of neuroleptic
treatment and various forms of paranoid schizophrenia.
Drug use indicator (DUI) methodology: random sample
of the DUI registration cards (each even medical chart
of each month) – 745 records for 2001 and 1281
records for 2002.
Movement disorders in schizophrenic patients
in the years 200-2002 and total daily
neuroleptic doses
Clinical form
2000
2001
2002
Daily neuroleptic
load (in oral
chlorpromazine mg)
paranoid
schizophrenia
n*/N**
paranoid
schizophrenia with
cerebral-organic
deficiency
n/N
schizophrenia with
hallucinativeparanoidal
sindrome
n/N
8%
7%
6%
99/1275
14%
84/1152
12%
42/306
46/372
54/448
12%
11%
10%
77/641
64/609
66/660
2547107 mg
67/1033
1653123 mg
12%
3053116 mg
*n - number of patients with movement disorders, **N – total number of patients
Prescribed daily doses of neuroleptics (in DDDs)
in patients – men and women, causing
movement disorders (2000-2002).
Neuroleptics
Women
DDD (Mm)
Men
DDD (Mm)
Haloperidol
2,73 0,11*
3,48 0,19
Chlorpromazine 1,64 0,2*
Clozapine
0,12 0,02*
2,96 0,23
0,54 0,17
* – p<0,05 difference between women and men.
Comparison of the number of cases of extrapyramdal
movement disorders in women and men with various
forms of schizophrenia (2000-2002).
paranoid
schizophrenia (PS)
200
case
150
PS with cerebralorganic deficiency
100
50
0
w omen
men
PS with
gallucinativeparanoidal sindrome
*-р < 0,05 - level of statistical significance of distinctions between women and
men.
The Drug Use Indicators in the Republican
Clinical Psychiatric Hospital of the Republic of
Tatarstan (2001, 2002).
Year
Number of
medicines
per patient
Medicines,
prescribed
under
generic
names
Number of cases
with antibiotics’
use
Number of
cases with
injection use
Prescribed
medicines,
belonging
to the
formulary
list
2001
8.3
56.7%
32.2%
38.8%
63.5%
2002
5,8
69,1%
10,6%
40,8%
99%
Discussion
The neuroleptics are needlessly overused in
treatment of paranoid schizophrenia.
Drug use monitoring was an effective measure to
improve the prescribing habits of psychiatrists.
Despite of achieved results the so called preventive
use of anticholinergics as well as polypharmacy in
antipsychotics’ prescription persisted.
This proves the necessity of introduction of
educational interventions for psychiatrists and the
importance of further drug use monitoring in this
field.
Conclusions:
The introduction of a
pharmacoepidemiological monitoring
system in a psychiatric clinical hospital
proved effective in reducing
polypharmacy, injection and antibiotic
use, and the total neuroleptic load and
adverse effects profile in schizophrenia
patients.
Conclusion - 2
Strength
Drug use and side effects monitoring methodology for
improvement of pharmacotherapy of schizophrenic
patients - Drug use indicators’ registration cards and
side effects’ registration cards in regular medical
charts
Weaknesses
Lack of educational intervention
What to do next
Monitor drug use and side effects and educate on
regular basis