Valproic Acid Use in Patients With Neurological Disorders

Neurological Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05830981
• Other study ID #: valproic acid therapy
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: December 31, 2017

Study information

• Verified date: July 2023
• Source: Damanhour University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: December 31, 2017
• Est. primary completion date: December 20, 2017
• Gender: All
• Age group: 10 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nervous System Diseases
• Neurological Disorders

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Damanhour University	Mansoura University

References & Publications (3)

Bell JS, Whitehead P, Aslani P, McLachlan AJ, Chen TF. Drug-related problems in the community setting: pharmacists' findings and recommendations for people with mental illnesses. Clin Drug Investig. 2006;26(7):415-25. doi: 10.2165/00044011-200626070-00003. — View Citation

Nanaumi Y, Yoshitani A, Onda M. Impact of interventions by a community pharmacist on care burden for people with dementia: development and randomized feasibility trial of an intervention protocol. Pilot Feasibility Stud. 2022 Jun 2;8(1):118. doi: 10.1186/s40814-022-01071-7. — View Citation

Thakkar KB, Jain MM, Billa G, Joshi A, Khobragade AA. A drug utilization study of psychotropic drugs prescribed in the psychiatry outpatient department of a tertiary care hospital. J Clin Diagn Res. 2013 Dec;7(12):2759-64. doi: 10.7860/JCDR/2013/6760.3885. Epub 2013 Dec 15. — View Citation

Outcome

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