Role of Clinical Pharmacists in Epilepsy Management

Sponsor
Gia Dinh People Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04967326
Collaborator
(none)
141
1
36

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Optimizing therapy with antiepileptic drugs (carbamazepine, phenytoin, valproic acid)
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
141 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Role of Clinical Pharmacists in Epilepsy Management at a General Hospital in Vietnam: A Before-and-after Study
Actual Study Start Date :
Jan 1, 2016
Actual Primary Completion Date :
Dec 31, 2018
Actual Study Completion Date :
Dec 31, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patients with epilepsy

The therapies of patients with epilepsy were optimized using pharmacists' interventions, including medication consultation, dosage adjustment, medication switching/discontinuation, or combination therapy.

Drug: Optimizing therapy with antiepileptic drugs (carbamazepine, phenytoin, valproic acid)

Outcome Measures

Primary Outcome Measures

  1. Number of patients with two seizures or less [One year from the start of the study]

    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

  1. Number of patients who maintained an optimized concentration of antiepileptic drugs [One year from the start of the study]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Gia Dinh People Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pham Hong Tham, Clinical pharmacist, Gia Dinh People Hospital
ClinicalTrials.gov Identifier:
NCT04967326
Other Study ID Numbers:
  • 23-2015/CN-HĐĐĐ
First Posted:
Jul 19, 2021
Last Update Posted:
Aug 2, 2021
Last Verified:
Jul 1, 2021
Keywords provided by Pham Hong Tham, Clinical pharmacist, Gia Dinh People Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 2, 2021