Role of Clinical Pharmacists in Epilepsy Management
Primary Purpose
Epilepsy
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Optimizing therapy with antiepileptic drugs (carbamazepine, phenytoin, valproic acid)
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring epilepsy, role of pharmacist, adverse drug reaction, antiepileptic drug, Vietnam
Eligibility Criteria
Inclusion Criteria:
- were prescribed a monotherapy or polytherapy of phenytoin, carbamazepine, or valproic acid.
- were treated for more than one month.
Exclusion Criteria:
- were pregnant or breastfeeding women.
- had a history of alcoholism.
- had liver or renal disease.
- were using drugs known to have an influence on cytochrome P450 enzymes.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with epilepsy
Arm Description
The therapies of patients with epilepsy were optimized using pharmacists' interventions, including medication consultation, dosage adjustment, medication switching/discontinuation, or combination therapy.
Outcomes
Primary Outcome Measures
Number of patients with two seizures or less
Patients with two seizures or less in a year were categorized as having good control, whereas those who had more were considered to have poor control.
Secondary Outcome Measures
Number of patients who maintained an optimized concentration of antiepileptic drugs
The targeted therapeutic ranges for carbamazepine, phenytoin, and valproic acid were 4-12 mg/L, 10-20 mg/L, and 50-100 mg/L, respectively.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04967326
Brief Title
Role of Clinical Pharmacists in Epilepsy Management
Official Title
Role of Clinical Pharmacists in Epilepsy Management at a General Hospital in Vietnam: A Before-and-after Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gia Dinh People Hospital
4. Oversight
5. Study Description
Brief Summary
Clinical pharmacists have an important role in inter-professional healthcare collaboration for epilepsy management. However, the pharmacy practices of managing epilepsy are still limited in Vietnam, deterring pharmacists from routine adjustments of antiepileptic drugs, which could decrease the patients' quality of life. This study aimed to assess the effectiveness of pharmacist interventions in epilepsy treatment at a Vietnamese general hospital.
Detailed Description
Phenytoin, carbamazepine, and valproic acid, which are among the first-generation AEDs, are prescribed in many countries around the world, including Vietnam. These agents have complicated pharmacokinetics, which may result in alterations in absorption, distribution, and metabolism. This means that, given the same dose, the serum concentration of each drug may vary between patients. The management of epilepsy, as a result, requires inter-professional collaboration to ensure therapeutic optimization. As healthcare professionals, clinical pharmacists play an important role in epilepsy management, which includes establishing a therapeutic drug monitoring (TDM) protocol, adjusting doses, monitoring ADRs, etc.
However, the clinical pharmacy practices in epilepsy management are quite limited in Vietnam. The treatment gap-the proportion of people with epilepsy who are not adequately treated-still remains very high, especially in rural areas (84.7%), which probably results from discontinuing the treatment or refusing to take medications. This shows a need for pharmacist consultations for patients with epilepsy and their family members, as they may be lack information about AEDs or motivation in controlling potential seizures. In addition, the adjustments of antiepileptic drugs by pharmacists are not routine procedures, nor are monitored for effectiveness in many Vietnamese hospitals. This lack of engagement threatens the patients' safety and decreases their quality of life. To address this issue, certain interventions are needed to enable pharmacists to manage patients with epilepsy more systematically. This study was therefore conducted to evaluate the effectiveness of pharmacist interventions in epilepsy treatment at a general hospital in Vietnam.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
epilepsy, role of pharmacist, adverse drug reaction, antiepileptic drug, Vietnam
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
141 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with epilepsy
Arm Type
Experimental
Arm Description
The therapies of patients with epilepsy were optimized using pharmacists' interventions, including medication consultation, dosage adjustment, medication switching/discontinuation, or combination therapy.
Intervention Type
Drug
Intervention Name(s)
Optimizing therapy with antiepileptic drugs (carbamazepine, phenytoin, valproic acid)
Primary Outcome Measure Information:
Title
Number of patients with two seizures or less
Description
Patients with two seizures or less in a year were categorized as having good control, whereas those who had more were considered to have poor control.
Time Frame
One year from the start of the study
Secondary Outcome Measure Information:
Title
Number of patients who maintained an optimized concentration of antiepileptic drugs
Description
The targeted therapeutic ranges for carbamazepine, phenytoin, and valproic acid were 4-12 mg/L, 10-20 mg/L, and 50-100 mg/L, respectively.
Time Frame
One year from the start of the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
were prescribed a monotherapy or polytherapy of phenytoin, carbamazepine, or valproic acid.
were treated for more than one month.
Exclusion Criteria:
were pregnant or breastfeeding women.
had a history of alcoholism.
had liver or renal disease.
were using drugs known to have an influence on cytochrome P450 enzymes.
12. IPD Sharing Statement
Citations:
PubMed Identifier
34930487
Citation
Pham HT, Tran MH, Nguyen NQ, Tan Vo V, Tran MH. Role of clinical pharmacists in epilepsy management at a general hospital in Vietnam: a before-and-after study. J Pharm Policy Pract. 2021 Dec 20;14(1):109. doi: 10.1186/s40545-021-00394-9.
Results Reference
derived
Learn more about this trial
Role of Clinical Pharmacists in Epilepsy Management
We'll reach out to this number within 24 hrs