Role of Clinical Pharmacists in Epilepsy Management

Gia Dinh People Hospital

Status and phase: Completed; Phase 4

Conditions: Epilepsy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04967326

23-2015/CN-HĐĐĐ

Details and patient eligibility

About

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.

Full 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.

Enrollment: 141 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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141 participants in 1 patient group

Patients with epilepsy

Experimental group

Description:

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

Treatment:

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