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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
Gia Dinh People Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    July 8, 2021
    Last Updated
    July 25, 2021
    Sponsor
    Gia Dinh People Hospital
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    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

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