Valproic Acid Use in Patients With Neurological Disorders

Study Overview
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Brief Summary
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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
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This retrospective prospective observational 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.

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

Conditions
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Neurological Disorders

Intervention / Treatment
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* Other: Educational intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Phase 1<br>n=600 | Other: Educational intervention<br>* 3 months of educational intervention (Lectures, information bulletin, handbook and hardcopy presentation slides) among professionals and patients.<br>* Other names: Educational &counselling sessions;|
| Phase 2<br>n=504 | Other: Educational intervention<br>* 3 months of educational intervention (Lectures, information bulletin, handbook and hardcopy presentation slides) among professionals and patients.<br>* Other names: Educational &counselling sessions;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Valproate use