Valproic Acid Use in Patients With Neurological Disorders

Not Applicable

Completed

• Conditions: Neurological Disorders
• Interventions: Other: Educational intervention

• Registration Number: NCT05830981
• Lead Sponsor: Damanhour University

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.

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2017-12-20
• Study Completion: 2017-12-31
• Study First Submitted: 2023-04-14
• Study First Submitted QC: 2023-04-14
• Study First Posted: 2023-04-26
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-28
• Last Update Posted: 2024-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Phase 2	Educational intervention	n=504

Primary Outcome Measures

Name	Time	Method
Valproate dose (Number)	3 month	Right dose
Number of drugs (Number)	3 Months	Number of drugs included in the prescriptions analyzed
Medication errors (Number)	3 Months	Medication errors regarding frequency or dose of Sodium valproate
Adherence (Number)	3 Months	Adherence to medication regimens
Tolerability (Number)	3 Months	tolerability was assessed through monitoring of ADRs and recorded in the patient's file.