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1.1       Introduction

1.1.1    Background of study

Epilepsy is the most common non-infectious neurologic disease in developing African countries including Nigeria and remains a major medical and social problem. It is a common neurologic disorder characterized by recurring seizures that may recur unpredictably in the absence of provoking factors (NICE, 2015). An epileptic seizure is a clinical presentation which is linked to an abnormal and excessive discharge from a set of neurons in a specific locus of the brain. This clinical manifestation consists of sudden and transitory abnormal phenomena which may include alterations in consciousness, motor, sensory, autonomic and psychic behaviors (NICE, 2015).

Epilepsy affects approximately 70 million people of all ages throughout the world. The worldwide prevalence of epilepsy is inconsistent and diversified among countries, but it is estimated that the overall prevalence is 10/1000 people (NICE, 2015). Persons with epilepsy are at a risk of developing a variety of psychological problems including depression, anxiety and psychosis (Kabir et al; 2005; Dalrymple & Appleby, 2000).The reported prevalence of active epilepsy in developing countries range from 5 to 10 per 1,000 people (Kabir et al; 2005; Ozer, 1991). In Nigeria, the estimated prevalence of epilepsy is 8 to 13 per thousand people (Azubuike & Nkanginieme, 1996). In developing countries, the disorder is to a significant degree associated with a host of parasitic and bacterial infectious diseases that are largely absent in industrialized countries (Matuja & Rwiza, 1994).

Most patients suffering from epilepsy in African countries prefer anonymity and are reluctant to disclose their condition because of the stigma attached to the disease. This factor affects the prevalence rates, hence there is likelihood that most of the reported prevalence rates are grossly underestimated as the chances of under-reporting are high. The prevalence rates of epilepsy reported in Africa are based on surveys of defined communities and hospital admissions (Osuntokun, 1978).

The goal of treatment of epilepsy is to maintain a normal lifestyle by complete seizure control with minimal side effects. Treatment is with pharmacological and non-pharmacological methods. Antiepileptic drugs (AEDs) therapy is the mainstay of treatment for the majority of patients. Non-pharmacological strategies are primarily reserved for drug-resistant epilepsy (Nwani et al; 2012).

Sociocultural attitudes continue to have a negative impact on management of epilepsy in many African countries (Nbukpo et al; 2003). The disorder is enrobed in superstition, discrimination and stigma in many of these countries (Ndour et al; 2004). Religious and socio-cultural beliefs influence the nature of treatment and care received by people with epilepsy. Many communities in Africa and other developing countries believe that epilepsy results from witchcraft or possession by evil spirits and therefore treatment should be through the use of herbs from traditional doctors, fetish priests and religious leaders. This contributes to deterioration of the patients’ condition and development of complications. Persons with epilepsy are shunned and discriminated against in education, employment and marriage in Africa because epilepsy is seen as a highly contagious and shameful disease in the eyes of the public. These observations came from many studies carried out in Africa, including Nigeria and Liberia (Nwani et al; 2012). Pioneer investigators in Nigeria have also presented a gloomy picture of epilepsy as a highly infectious and disastrous disease in the eyes of the public.

The social implication of epilepsy is serious. In Madagascar and many African countries, patients with epilepsy are refused burial in the family grave. In many African countries, the patient with epilepsy is an outcast as it is believed that the disease results from visitation of the devil, effect of witchcraft, the revenge of an aggrieved ancestral spirit or consumption of something harmful in utero (Olunbunmi, 2006). Myths and misconceptions about epilepsy abound and are deep rooted, resulting in considerable stigma and discrimination leading to a wide treatment gap, particularly in developing countries. Stigma attached to epilepsy and the misconceptions about the disease often contribute to a greater burden than the disease itself (Gourie-Devi et al; 2010).  Stigma can have significant negative influence on treatment seeking behaviour, quality of life encompassing all spheres of life including education, employment, marriage, child bearing and accrual of social benefits. Discrimination at school, job and by friends, spouse and family members adds to the burden (Gourie-Devi et al; 2010). Social discrimination affects not only the person with epilepsy but also the family members. The perception of stigma about epilepsy varies widely across countries and is considerably more in developing countries compared to the developed nations. In the developed nations high level of literacy, mass communication through media and wider reach of health care to the community have resulted in better understanding of the nature of epilepsy and remarkable decline in wrong perceptions and myths about the disease (Caveness & Gallup, 1980). However, in countries with low resources, poor awareness about epilepsy, stigma associated with the disorder, ignorance that it is a treatable disorder and restricted access to health care have a negative influence on the quality of life (Gourie-Devi et al; 2010).

1.1.2    Statement of Problem and Justification of the study

It has been observed that a patient’s knowledge and understanding of their condition has a significant role to play in providing good quality outcomes for the patient. A betterinformed patient with epilepsy will be more likely to provide relevant information to their healthcare provider to aid in diagnosis. Also, well informed patients will achieve better compliance with drug therapy, thereby leading to better seizure control.

Studies carried out amongst people with diabetes have found that education and counseling programs produces significant improvements in long-term control. However, insufficient information regarding what patients with epilepsy actually know about their disorder is available. A study in America reported that patients with epilepsy are ill-informed about their disorder, irrespective of their age, educational background, or number of years with epilepsy (National Epilepsy Week Special Feature). Another study carried out by the Department of Neurology at St. James Hospital and the School of Medicine, Trinity College, concluded that many people with epilepsy are not well informed about their disorder (National Epilepsy Week Special Feature).

A study in the United Kingdom found that the majority of those interviewed with epilepsy were generally unaware of their seizure type and indications for their antiepileptic drug therapy (National Epilepsy Week Special Feature).

In terms of awareness and social acceptance, numerous surveys carried out on general populations of developing countries report that people with epilepsy are often viewed with attitudes that become breeding ground for myths, stigma and exclusion (Al-Dawi et al; 2003; Al-Dawi et al; 2001). Unfortunately, there is the sufficient evidence suggesting that, on average, even healthcare providers in developing countries still harbor some negative attitudes toward people with epilepsy (Al-Dawi et al; 2003; Al-Dawi et al; 2000). These negative attitudes can be addressed by ensuring that the patients have a good understanding of their condition. Without sufficient knowledge, people with epilepsy are likely to become the victims of other people’s wrong beliefs and misconceptions. Earlier studies suggest that there is a direct relationship between patients’ understanding of their disability and their evolving proper coping mechanisms (Al-Dawi et al; 2003; Baker et al; 1999).

Through self-care, every patient can immensely contribute to the management of their diseases. By ensuring patients’ understanding of their disability and the coping mechanisms, people with epilepsy can achieve a great degree of control over their seizures, making it possible for a greater self-management of the seizures. The people with epilepsy may be more aware of their own needs and of the services available to meet those needs (Betts, 1992). The self-advocacy skills of the people with epilepsy may also improve, which puts them in a better position to explain their condition to others and thereby promote a positive view of epilepsy (Cockran, 1995). Studies have revealed that people with epilepsy know only a little more, and in some cases may even know less, about their disorder than those without epilepsy (Baker et al; 1999; Dawkins et al; 1993). Long et al in their study assessed the knowledge of people with epilepsy about their disorder as it regards safety, compliance and legal issues concerning driving and employment (Long et al; 2000). This study also revealed that, irrespective of demographic parameters such as age, education and duration of the illness, people with epilepsy tend to have limited knowledge about their condition (Long et al; 2000). As a result of this, people with epilepsy may be less likely to come to terms with their condition. Studies carried out in developing countries have examined cultural attitudes and awareness of epilepsy (Al-Dawi et al; 2003; Kleinman et al; 1995).  However, not many investigations have been conducted to evaluate the knowledge of people with epilepsy of their condition. In Nigeria, adequate information on the knowledge and attitude regarding epilepsy among epileptic patients is lacking. As the incidence and prevalence of epilepsy are thought to be several-fold higher in developing than in industrialized countries, there is clearly a pressing need for examining how much patients from developing countries with epilepsy understand about their disease (Thoedore, 2000).

Health education has been shown to improve the adherence of patients to their anti-epileptic medication (Ibinda et al; 2014). A randomized controlled trial in Europe found that patient education improved knowledge about epilepsy, coping strategies, and seizure outcome (May & Pfafflin, 2002). Demonstration projects in rural China improved biomedical care using education and treatment interventions (Lil et al; 2007).  However, the findings from these studies cannot be extrapolated to Nigeria due to different socio-cultural backgrounds and health systems.

The implementation and evaluation of pharmaceutical care interventions for epileptic patients within the Nigerian healthcare system is yet to be done. Thus, our research questions are:

        i.            Is the development, implementation and evaluation of pharmaceutical care for the Nigerian epileptic patient population feasible?

      ii.            Are pharmaceutical care interventions for the Nigerian epileptic patient capable of improving clinical outcomes?

    iii.            Are pharmaceutical care interventions for the Nigerian epileptic patient capable of improving the quality of life of the patient?

1.2       Definition and classification of seizures and epilepsy

A seizure can be defined as a paroxysmal distortion of neurologic function resulting from the excessive, hyper- synchronous discharge of neurons in the brain.  Seizures occur when there is an alteration in the normal balance between excitation and inhibition in the brain (Stafstrom and Carmant 2015). This excitation/inhibition imbalance may arise due to alterations at different levels of brain function, from genes and sub-cellular signaling cascades to widespread neuronal circuits. The factors that distort the excitatory/inhibitory balance can be acquired or genetic. Genetic abnormalities leading to epilepsy can occur anywhere from the circuit level (e.g., abnormal synaptic connectivity in cortical dysplasia) to the receptor level (e.g., abnormal g-aminobutyric acid [GABA] receptor subunits in Angelman syndrome) to abnormal ionic channel function (e.g., potassium channel mutations in benign familial neonatal epilepsy). Also, acquired cerebral insults can alter circuit function (e.g., structural alteration of hippocampal circuitry following prolonged febrile seizures or head trauma) (Stafstrom and Carmant 2015).

An epileptic seizure is different from other types of seizures (such as psychogenic seizure) that is caused by abnormal neuronal firing provoked by a reversible insult (such as fever, hypoglycemia) that is short lived and described as non-epileptic events. Epilepsy is a chronic condition characterized by recurrent, unprovoked seizures.

The term “Epilepsy syndrome” is used to refer to a group of clinical characteristics that occurs consistently together, with similar seizure type(s), age of onset, electroencephalogram findings, triggering factors, genetics, natural history, prognosis, and response to antiepileptic drugs.

Over the years epilepsy was believed to be a disorder or a group of disorders rather than a disease. However, recently the ILAE and the International Bureau for Epilepsy (IBE) have defined epilepsy as a disease. An individual who has had a seizure and a brain pathology that predisposes the individual to having recurrent seizures is considered to be epileptic.

A 2014 ILAE report defines epilepsy as a disease of the brain characterized by the following; at least two unprovoked or reflex seizures occurring greater than 24 hours apart, one unprovoked or reflex seizure with a probability of further seizures similar to the general recurrence risk (at least 60%) after two unprovoked seizures, occurring over the next 10 years, and a diagnosis of an epilepsy syndrome. Unprovoked in this context refers to the absence of a temporary or reversible factor that can lower the seizure threshold and induce a seizure (Fisher et al 2014).

A seizure that is stimulated after a concussion, or associated with fever, or in association with alcohol-withdrawal, is a provoked seizure that would not necessarily result in a diagnosis of epilepsy. However, provoked seizures, for instance caused by photic stimuli are defined as epilepsy. In this case, even though the seizure is provoked, it still fits the definition of epilepsy conceptually, because the reflex epilepsies are characterized by an enduring abnormal predisposition to having such seizures (Harding, 2004).

The brain pathology responsible for epilepsy is believed to lower seizure threshold in epileptics, when compared to persons without the condition. A seizure that is caused by momentary factor acting on an otherwise normal brain to briefly lower the seizure threshold is not considered as epilepsy. Epilepsy is not a life-long condition in many cases. It can be said to be resolved in persons who had an age-dependent epilepsy syndrome but are now past the applicable age or persons who have remained seizure-free for the past 10 years and have been without antiepileptic medicines for the past 5 years (Fisher et al, 2014).

Brief seizures have traditionally been defined as lasting less as 5 minutes, with prolonged seizures defined as lasting between 5 and 30 minutes. On the other hand, status epilepticus is defined as seizures lasting more than 30 minutes either as continuous seizure activity or two or more sequential seizures without full recovery of consciousness between the seizures (Glauser et al, 2016; Glauser, 2007). This 30-minute definition is based on the duration of convulsive status epilepticus that may result in a permanent neuronal injury by itself (Glauser et al, 2016). Since the majority of seizure cases are brief by definition, and once a seizure lasts more than 5 minutes it is reported to be prolonged (Shinnar et al, 2001), status treatment protocols have used a 5-minute benchmark to minimize both the risk of seizures reaching 30 minutes and the untoward outcomes associated with needlessly intervening on brief, self-limited seizures ((Glauser et al, 2016; Raspall et al, 2007).

Status epilepticus (SE) as defined by ILAE is a condition characterized by an epileptic seizure that is sufficiently prolonged or repeated at sufficiently brief intervals so as to produce an unvarying and enduring epileptic condition. This definition does not provide a precise definition of the duration of status epilepticus, hence different operational definitions of status epilepticus have been given in textbooks, research papers and clinical trials (Trinka et al, 2015). Generalized tonic-clonic SE in adults and children older than 5 years has been operationally defined as a continuous seizure greater than 5 minutes in duration, or 2 or more discrete seizures between which consciousness is not completely recovered (Lowenstein, 1999). The time frame of 5 minutes has been generally accepted by the clinicians and is used as guide in determining when emergency treatment of generalized tonic-clonic status epilepticus should commence.

Focal seizures with impaired consciousness lasting for 10 minutes or more are considered SE and emergency treatment should be instituted. Absence seizures lasting for about 10 – 15 minutes is SE and requires emergency treatment to avoid long-term complications such as neuronal injury, neuronal death, alteration of neuronal networks and functional deficit (Trinka et al, 2015).

Seizure Classification

Classification is the way in which items are organized and clinically differentiated. It serves several purposes including; facilitating communication between clinicians as it provides them with a common terminology, improving the treatment of patients, guiding of basic research to identify natural classes which will then form the basis of future scientific classifications (Trinka et al, 2015).

Distinction of seizure types is usually achieved by identifying the sequence of symptoms and other clinical observations. Seizure classification should begin with a historical elicitation of the semiology (i.e. the signs and symptoms) that are associated with seizures. However, in many cases some symptoms may present in more than one seizure type. For instance, behavior arrest may occur in both focal impaired awareness seizures and absence seizures; also, tonic-clonic activity can be seen from onset in a generalized seizure or may occur during the course of a focal onset seizure (Fisher et al, 2017).

Furthermore, a seizure type is usually associated with multiple symptoms. For example, tonic seizures can have either a focal or generalized onset. Without the knowledge of the onset, a seizure may be termed as being unclassifiable.