Undue regulatory control on phenobarbital—an important yet overlooked reason for the epilepsy treatment gap

Abstract

International audienceEpilepsy is a major chronic noncommunicable neurologic disorder. Although a simple, safe, efficacious, and low-cost treatment has been available for nearly 100 years, the treatment gap remains disturbingly high in many low- and middle-income countries (LMICs).[1] Treatment gap is generally defined as a “difference between the number of people with active epilepsy and the number being appropriately treated.” There are many reasons for this treatment gap; one important reason is an overly restrictive regulation on barbiturates such as phenobarbital (PB). These restrictive regulations deserve a wider and open discussion, even though epileptologists and others are intensely engaged on reducing the epilepsy treatment gap. With this article, we provide our viewpoint with an aim of raising an extremely important issue: undue regulatory restriction on phenobarbital, an essential lifesaving antiepileptic drug (AED)

A retrospective observational study of EEG findings and antiepileptic drug use among children referred for EEG to Zambia's University Teaching Hospital

“…Historically, phenobarbitone has been the mainstay of epilepsy management in SSA, having the advantages of broad spectrum coverage (although with poor efficacy in absence and myoclonic epilepsy) and a simple dosing regimen at a very low cost. In the past decade, the introduction and expansion of drug regulatory activities and enforcement have significantly increased the cost of phenobarbitone and diminished the overall availability, leading to significant negative effects on the treatment of epilepsy, particularly in remote areas where phenobarbitone is the only accessible AED . The disappearance of phenobarbitone further escalates the need for electrodiagnostic insights at the individual and population level in SSA.…”

Global Health: Pediatric Neurology

“…61 A new challenge to drug availability has arisen recently as many low-income countries have been experiencing an erratic supply of phenobarbital due to restrictive legislation that treats all barbiturates as controlled substances. 62 This has potentially catastrophic consequences, as patients who are unable to locate phenobarbital may experience drug withdrawal and status epilepticus, a particular concern for patients living in rural areas. 61,62 Other nonpharmacological interventions such as the ketogenic diet, vagal nerve stimulation, and other epilepsy surgeries are largely not available in low-resource settings, as they require a high level of medical expertise and financial resources.…”

“…62 This has potentially catastrophic consequences, as patients who are unable to locate phenobarbital may experience drug withdrawal and status epilepticus, a particular concern for patients living in rural areas. 61,62 Other nonpharmacological interventions such as the ketogenic diet, vagal nerve stimulation, and other epilepsy surgeries are largely not available in low-resource settings, as they require a high level of medical expertise and financial resources. For example, only three countries in Sub-Saharan Africa (Kenya, South Africa, and Uganda) offer epilepsy surgery, 30 and according to the recent data from the WHO, only 16% of the responding 105 countries have epilepsy surgery units.…”

Availability and sufficiency of phenobarbital, an essential medication, in Bhutan: a survey of global and neuropsychiatric relevance

“…Generally, PB has a broad anti-seizure (partial and generalised) activity, including neonatal seizures and < 20 min status epilepticus. In resource-poor countries, PB is fundamental, most widely used, and often times the only available or affordable ASM [ 3 , 6 , 11 ]. In developed countries where neurotoxic concerns of PB are reportedly ‘felt’ more, other ASMs have superceded but not necessarily for the right reasons [ 6 , 12 , 13 ].…”

“…In resource-poor countries, PB is fundamental, most widely used, and often times the only available or affordable ASM [ 3 , 6 , 11 ]. In developed countries where neurotoxic concerns of PB are reportedly ‘felt’ more, other ASMs have superceded but not necessarily for the right reasons [ 6 , 12 , 13 ]. The position of PB has also been compromised due to its low retail price (low profit margin) and inappropriate marketing of its safety profile.…”