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Valproic Acid Use in Patients With Neurological Disorders

Valproic Acid Use Evaluation in Patients With Neurological Disorders: a Retrospective and Prospective Analysis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05830981
Enrollment
600
Registered
2023-04-26
Start date
2015-01-01
Completion date
2017-12-31
Last updated
2024-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurological Disorders

Keywords

Valproate use

Brief summary

Sodium valproate is a well-known anticonvulsant used in the treatment of epilepsy and bipolar disorder, as well as other psychiatric conditions requiring the administration of mood stabilizers. Aim of the present study is to assess sodium valproate usage among patients with neurological disorders. Prescriptions of 600 patients from out-patient pharmacy of neurology department at Mansoura university teaching hospital were analyzed in a retrospective prospective observational study which conducted between January 2015 and December 2017. Data collected include: demographic data, medical history, drug-drug interaction, polypharmacy, medication error, doses and therapeutic duplication. A designed and structured form was used to collect the required information.

Detailed description

This quasi-experimental pretest-posttest design study was conducted at the outpatient's pharmacy of Neurology department at tertiary care hospital. After identifying problems with use and completing a follow-up, 3 months of educational intervention (Lectures) among professionals was given. As this study is observational informed consent from all subjects was waived. The subjects were enrolled on the basis of inclusion and exclusion criteria. Patients receiving at least 7 days of Valproic acid, between 10-70 years old, both sexes, were included in the study figure 1. 600 Prescriptions were reviewed between January of 2015 to December of 2017 for patients who were suffering from any psychotic illness and were on psychiatric medications. Then pharmacist educational intervention started and followed up for three months then prescriptions re-evaluted. Inclusion/ exclusion criteria: The study population was limited to those who were continuously eligible for the outpatient pharmacy refilling thier medications during the entire study period. Patients were identified through pharmacy drug prescriptions By hospital policy all drugs are prescribed for a maximum period of 3 months. Consequently, all patients presented at least twice during the study period. A designed and structured form was used to collect the required information. Data then collected on Microsoft Excel sheet, which included patients' initial therapeutic indications, concomitant use of oral medications, significant adverse drug effects and any drug -drug interaction.

Interventions

OTHEREducational intervention

3 months of educational intervention (Lectures, information bulletin, handbook and hardcopy presentation slides) among professionals and patients.

Sponsors

Mansoura University
CollaboratorOTHER
Damanhour University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
NONE

Intervention model description

A quasi-experimental pretest-posttest design study.

Eligibility

Sex/Gender
ALL
Age
10 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* The study population was limited to those who prescribed with valproate and were continuously eligible for the outpatient during the entire study period. Patients were identified through pharmacy drug prescriptions By hospital policy all drugs are prescribed for a maximum period of 3 months. Consequently, all patients presented at least twice during the study period.

Exclusion criteria

* Patients who not use valproate.

Design outcomes

Primary

MeasureTime frameDescription
Tolerability (Number)3 Monthstolerability was assessed through monitoring of ADRs and recorded in the patient's file.
Valproate dose (Number)3 monthRight dose
Number of drugs (Number)3 MonthsNumber of drugs included in the prescriptions analyzed
Medication errors (Number)3 MonthsMedication errors regarding frequency or dose of Sodium valproate
Adherence (Number)3 MonthsAdherence to medication regimens

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026