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A variety of terms, such as "antiepileptic," "anticonvulsant," and "antiseizure" have been historically applied to medications for the treatment of seizure disorders. Terminology is important because using terms that do not accurately reflect the action of specific treatments may result in a misunderstanding of their effects and inappropriate use. The present International League Against Epilepsy (ILAE) position paper used a Delphi approach to develop recommendations on English‐language terminology applicable to pharmacological agents currently approved for treating seizure disorders. There was consensus that these medications should be collectively named "antiseizure medications". This term accurately reflects their primarily symptomatic effect against seizures and reduces the possibility of health care practitioners, patients, or caregivers having undue expectations or an incorrect understanding of the real action of these medications. The term "antiseizure" to describe these agents does not exclude the possibility of beneficial effects on the course of the disease and comorbidities that result from the downstream effects of seizures, whenever these beneficial effects can be explained solely by the suppression of seizure activity. It is acknowledged that other treatments, mostly under development, can exert direct favorable actions on the underlying disease or its progression, by having "antiepileptogenic" or "disease‐modifying" effects. A more‐refined terminology to describe precisely these actions needs to be developed. [ABSTRACT FROM AUTHOR]

Older people are often affected by impaired organ and bodily functions resulting in multimorbidity and polypharmacy, turning them into the main user group of many medicines. Very often, medicines have not specifically been developed for older people, causing practical medication problems for them like limited availability of easy to swallow formulations, easy to open packaging and dosing instructions for enteral administration. In 2020, the European Medicines Agency (EMA) published a reflection paper 'Pharmaceutical development of medicines for use in the older population', which discusses how the emerging needs of an ageing European population can be addressed by medicines regulation. The paper intends to help industry to better consider the needs of older people during pharmaceutical/clinical medicines development by summarising data on the most relevant topics, providing early suggestions on how to move forward and prompting expert discussions and studies into knowledge gaps. Topics include patient acceptability, (dis)advantages of an administration route, formulation, dosage form, packaging, dosing device and user instruction. While the paper is directed at older people and the pharmaceutical industry, the reflections are also relevant to younger patients with similar disease‐related needs and of value to other stakeholders parties, e.g., healthcare professionals, academics, patients and caregivers, as the paper makes clear what can be expected from industry and where collaborative work is needed. This commentary provides an overview of the different steps in the development of the reflection paper, discusses points considered most controversial and/or subject to (multidisciplinary) expert discussions and indicates their value for real world clinical practice. [ABSTRACT FROM AUTHOR]

Objective: The Patient Information Leaflet (PIL) is an authoritative document that all people with epilepsy in the EU receive when prescribed antiseizure medication (ASM). We undertook the first independent, comprehensive assessment to determine how understandable they are. Regulators state that when patients are asked comprehension questions about them, ≥80% should answer correctly. Also, recommended is that PILs have a maximum reading requirement of US grade 8. Methods: Study 1: We obtained 140 current ASM PILs written in English. "Readability" was assessed using four tests, with and without adjustment for influence of familiar, polysyllabic words. A total of 179 online materials on epilepsy were also assessed. Study 2: Two PILs from Study 1 were randomly selected (Pregabalin Focus; Inovelon) and shown to 35 people from the UK epilepsy population. Their comprehension was assessed. Study 3: To understand whether the student population provides an accessible alternative population for future examination of ASM PILs, Study 3 was completed, using the same methods as Study 2, except that participants were 262 UK university students. Results: Study 1: No PIL had a reading level of grade 8. Median was grade 11. Adjusting for context, the PILs were still at grade 10.5. PILs for branded ASMs were most readable. PILs were no more readable than (unregulated) online materials. Study 2: Users struggled to comprehend the PILs' key messages. The eight questions asked about pregabalin were typically answered correctly by 54%. For Inovelon, it was 62%. Study 3: Most student participants comprehended the PILs' key messages. The questions about Inovelon were answered correctly by 90%; for pregabalin it was 86%. Significance: This is the first independent and comprehensive examination of ASM PILs. It found that PILs being used fail to meet recommendations and regulatory requirements and risk not being understandable to a substantial proportion of users. In finding that people from the epilepsy population differ markedly in comprehension of PILs compared to students, this study highlights the importance of completing user testing with the target population. [ABSTRACT FROM AUTHOR]

Increased global longevity requires a re‐evaluation of current structures in society to adapt to the consequential demographic shift. As (very) old people are prone to impaired human organ and body functions resulting in, for example, multimorbidity, polypharmacy, hospitalisation and problems in medication management, it is increasingly acknowledged that re‐evaluations should include the suitability of pharmaceutical patient care as one of the cornerstones of public health. Following the 2011 European Medicines Agency (EMA) Geriatric Strategy, in 2017 the EMA published the draft "Reflection paper on the pharmaceutical development of medicines for use in the older population". The draft paper was opened for public consultation and specific attention and feedback (either supportive or with a proposal for revision) was asked on three design aspects: tablet breaking, drug administration through enteral feeding tubes and medication management. Following publication, the draft paper was presented at two public conferences attended by participants from different disciplines. This manuscript is intended to draw the attention of different stakeholder parties to the urgent need to collaborate on the emerging issues arising from increasing longevity and multimorbidity, and especially those associated with pharmaceutical patient care and drug product design, including the need for collaborative research into existing or emerging knowledge gaps. The manuscript focuses on the three aforementioned aspects of pharmaceutical development (tablet breaking, drug administration through enteral feeding tubes and medication management) as these highly relate to medication safety and efficacy and constitute persistent and typical challenges for older people, caregivers and healthcare professionals in daily clinical practice. [ABSTRACT FROM AUTHOR]

The benefit of using the adapters as opposed to patient self-reporting of medication use is objective monitoring of patient adherence to their assigned medication protocol. Keywords: dermatology; electronic monitoring; medication adherence; topical medication EN dermatology electronic monitoring medication adherence topical medication 371 373 3 03/25/22 20220301 NES 220301 INTRODUCTION Medication nonadherence is associated with increased disease severity and poor disease outcomes. [Extracted from the article]

The Medicines and Healthcare products Regulatory Agency was established in April 2003 by the merger of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA). This paper describes the scientific and organizational basis for the merger and describes the various challenges facing this new Agency. [ABSTRACT FROM AUTHOR]

A Case of Ictal Fear with Various Psychiatric Manifestations and Memory Disturbance in Interictal Stages.Purpose:Ictal emotion corresponds to“affective seizures,” according to the Proposal for Revised Clinical and Electroencephalographic Classification of Epileptic Seizures by the International League Against Epilepsy (ILAE; 1981), and is characterized by the appearance of affective disorders such as fear, depression, pleasure, and anger. In particular, the ictal emotion, in which fear is the most commonly noted emotion, is referred to as“ictal fear.” In the present study, we report a patient with temporal lobe epilepsy, who showed ictal fear associated with various psychiatric manifestations including memory disturbance in the interictal stage that promptly subsided with antiepileptic drug (AED) administration.Case Report:A 24-year-old woman had recurrent episodes fear and anxiety. Family risk factors consisted of major depression in the maternal grandmother, but no familial history of epilepsy. The patient had a history of mumps with fever of 38°C at age 6 years without febrile convulsion. The present illness began around April 1997, when the patient became aware of swelling of the left ear membrane and a tinnitus-like noise, with an occasional feeling of her entire body floating in air. On March 6, 2000, severe giddiness suddenly developed, and from April of that year, she had pronounced drowsiness and hypersomnia. From January 2001, her giddiness and feeling of dizziness became marked, and she was overcome by an unpleasant feeling from January 16 to 17. From January 18 to 19 and on February 7 and 8 she manifested emotional lability. She had a depressive mood on February 22 and reversed to an elated mood the following day. On March 6, she experienced sudden severe left ear pain, which was diagnosed as migraine at a department of neurosurgery in another hospital. In addition, from about this time, anxiety and vague feeling of panic developed. From around April, she experienced autonomic seizures lasting 20 s, characterized by abnormal sensations of gooseflesh and coldness extending from the left posterior neck to cheek. These seizures occurred at a frequency of 20 to 30 times a day. Furthermore, she showed increased anxiety, depressive mood, and palpitations with feeling of left chest constriction in the interictal period. On May 25 and 26, autonomic seizures consisted of sudden severe nausea, and from June were characterized by a feeling of gooseflesh and coldness extending from the upper to lower arms bilaterally. The duration of these seizures was 10–20 s, and the frequency was 10 times/day. From the same period, she had various psychiatric symptoms such as hypobulia, declining activity, and a sense of guilt in the interictal period. From around August, her unpleasant feeling gradually worsened, and her voice became low, and her actions became slow. Furthermore, hypochondriacal and depressive symptoms became more marked, and appetite decreased, with the appearance of insomnia and suicidal ideation. On August 28, generalized tonic–clonic seizures (GTCSs) occurred twice, and after the first GTCS, she had ictal fear lasting 60–120 s, which occurred at a frequency of 4 to 5 times per day. The experience of ictal fear was engendered by the patient imagining a scene in which she was enveloped in the dark by some fearful thing and pursued by something of an unknown nature. Subsequently, her parents witnessed her screaming during the ictal fear. On September 21, she was admitted to our hospital for detailed examinations and treatment.Both the ictal and interictal symptoms improved with increasing doses of carbamazepine (CBZ). Clinical examinations revealed no particular hematologic or biochemical abnormalities, and the neurologic examination was normal. Psychometric examination showed FIQ, 87[verbal IQ (VIQ) 94; performance IQ (PIQ), 82] on the WAIS-R, with procedural memory showing a learning effect in both mirror drawing and tower of Hanoi puzzle. Interictal EEGs showed generalized high-amplitude slow-burst 6- to 7-Hz train, which disappeared after CBZ administration. Fluid-attenuated inversion recovery (FLAIR) images of sagittal magnetic resonance imaging (MRI) revealed high signal intensity areas in bilateral amygdala and hippocampal regions.[99mTc]-HMPAO single-photon emission computed tomography (SPECT) images depicted hypoperfusion findings in the right medial temporal lobe.Discussion:This case had onset of epilepsy at age 20 years, and her symptoms were initially diagnosed as migraine and anxiety disorder. At the time of admission to our hospital, memory disturbance and various psychiatric symptoms such as a sensation of fear, anxiety, and depression were noted, so that the presence of anxiety disorder and dissociative disorder was suspected. However, based on the EEG and brain-imaging findings, a diagnosis of epilepsy was made. The notable features in this case are summarized as follows: (a) simple partial seizures consisting primarily of ictal emotions associated with the experience of fear; (b) interictal symptoms including various psychiatric manifestations such as manic–depressive and anxiety symptoms and memory disturbance; (c) abnormal MRI and SPECT images in the medial temporal lobes, possibly compatible with hippocampal sclerosis; and (d) rapid amelioration of the ictal and interictal symptoms with CBZ administration, accompanied by the disappearance of the generalized high-amplitude slow waves on the EEG.Conclusions:These findings suggest that ictal emotion is induced by localized focal seizures in the hippocampus and the adjacent limbic system including the amygdala. Moreover, the fact that CBZ administration ameliorated the interictal symptoms comprising various psychiatric manifestations and memory disturbances suggests that functional dysfunction associated with enhanced interictal discharges in the limbic system caused the interictal symptoms. Etiologic Analysis of Epilepsy in Children.Purpose:A population-based neuroepidemiologic survey of childhood epilepsy was conducted in the Okayama Prefecture on December 31, 1999, as the prevalence day. We analyzed the presumptive causes in this survey to clarify the causes of childhood epilepsy in the general population.Methods:The segment of the population younger than 13 years in the Okayama Prefecture on the prevalence day was 250,997. The lists of children with epilepsy were collected from the medical records of 84 hospitals and clinics in and around Okayama Prefecture, and 2,220 cases were identified; the prevalence rate was 8.8 per 1,000. In this study, EEGs were examined in 99.3% of the cases. The 2,220 cases, however, included 889 cases with single seizures or seizures induced by fever, because they were diagnosed as epilepsy by definite EEG abnormalities. Generally, cases of single seizures or seizures induced by fever are excluded from epileptic seizures in epidemiologic studies. When the 889 cases are excluded, the prevalence rate for the 1,331 cases decreased to 5.3 per 1,000. The former 2,220 cases and the latter 1,331 cases were designated as group A and group B, respectively. An etiologic analysis was carried out in the two groups.Results:Group A: (a) Presumptive causes were identified in 816 (37.8%) cases, and 1,341 (60.4%) cases had unknown etiology. The other 63 (2.8%) cases were excluded from the total because of a lack of etiologic information. (b) Predisposition to convulsions or epilepsy within second-degree relatives was found in 20.3%. (c) Prenatal causes consisted of genetic neurologic diseases in 1.4%, chromosomal aberrations or malformations in 2.0%, cerebral dysgenesis in 2.0%, intrauterine infection in 0.1%, and congenital hydrocephalus in 0.4%. (d) Perinatal causes consisted of premature birth with a low birthweight in 3.2% and neonatal asphyxia or abnormal delivery in 4.8%. (e) Postnatal causes consisted of encephalitis or meningitis in 2.7%, intracranial hemorrhage or vascular disorder in 0.9%, head trauma in 0.6%, and brain tumor in 0.2%. Group B: (a) Presumptive causes were identified in 562 (42.2%) cases, and 735 (55.2%) cases had unknown etiology. The other 34 (2.6%) cases were excluded from the total because of a lack of etiologic information. (b) Predisposition to convulsion or epilepsy within second-degree relatives was found in 18.9%. (c) Prenatal causes consisted of genetic neurologic diseases in 2.1%, chromosomal aberrations or malformations in 2.8%, cerebral dysgenesis in 2.6%, intrauterine infection in 0.2%, and congenital hydrocephalus in 0.6%. (d) Perinatal causes consisted of premature birth with a low birthweight in 3.9%, and neonatal asphyxia or abnormal delivery in 6.8%. (e) Postnatal causes consisted of encerder in 1.4%, head trauma in 0.8%, and brain tumor in 0.3%. (f) No significant differences in the prevalence of etiologic factors were noted between groups A and B.Conclusions:These findings indicate the etiologic distribution of childhood epilepsy in the general population. Comparison of Neuropsychological Findings Before Temporal Lobectomy Between Patients with Both Amygdalohippocampal Seizures and Psychotic Manifestations and Patients with Only Seizures.Purpose:The objectives of the study were to classify patients with amygdalohippocampal seizures into two groups according to the status of psychotic manifestations such as delusion and hallucination and to compare the neuropsychological findings.Subjects and Methods:We reviewed the neuropsychological findings of 28 patients (14 male, 14 female patients) who underwent temporal lobectomy and classified them into patients with psychotic manifestations such as hallucination and delusion (group P) and patients without them (group N). All patients underwent neuropsychological examinations including the Japanese Wechsler Adult Intelligence Scale–Revised (WAIS-R), Minnesota Multiphasic Personality Inventory (MMPI), Japanese Wechsler Memory Scale–Revised (WMS-R), verbal paired-associates learning test, story recall test, Benton's visual retention test, Rey-Osterrieth's complex figure test, Kana pick-out test, Japanese Raven's colored progressive matrices, and Japanese western aphasia battery.Results:The 28 patients who underwent anterior temporal lobectomy had a mean age at surgery of 36.0 years and mean age at seizure onset of 13.8 years. They were composed of 15 patients with right-sided temporal resection and 13 patients with left-sided temporal resection. According to psychotic manifestations, we classified them into the groups P and N. Group P group consisted of seven patients (25% of all patients) whose mean age at surgery was 39.6 years and mean age at seizure onset was 10.9 years. Group N consisted of 21 patients (75%) whose mean age at surgery was 34.8 years and mean age at seizure onset was 14.8 years. No statistically significant differences were found in the ages at surgery and seizure onset. The scores, determined by using Benton's visual retention test (fail), were higher (p<0.05) in group P than in group N. The scores determined by using the depression (D), psychopathic deviation (Pd), paranoia (Pa), psychasthenia (Pt), schizophrenia (Sc) scales of MMPI were higher (p<0.05) in group P than in group N. The scores of the WMS-R attention/concentration test, verbal paired-associates learning test, story recall test, and Benton's visual retention test (pass) (p<0.05) were higher in group N than in group P. The patient background of group P was as follows: Group P consisted of one male and six females; three of whom had febrile seizures. One patient had right-sided temporal resection, and six patients had left-sided temporal resection. The mean age of psychotic manifestation development was 33.4 years. The psychotic manifestations were characterized by visual hallucinations in three patients, and delusion of reference and persecution in seven patients. The average number of antiepileptic drugs (AEDs) used was 2.9, and the major AEDs were phenytoin, carbamazepine, zonisamide, and clonazepam. Four patients were married, two patients were unmarried, and one patient was divorced. The educational level was junior high school in two patients, high school in three patients, and technical college in two patients. The WAIS-R IQ was 81.9; verbal IQ was 82.6; and performance IQ was 84.6.Conclusions:Group P was distinguished from group N by the clinical scales such as the D (p<0.05), Pd (p<0.05), Pt (p<0.05), Pa (p<0.01), and Sc (p<0.01) scales of the MMPI. Thus the MMPI is a useful tool for determining patients with psychotic manifestations. The attention/concentration results in the WMS-R, verbal paired-associate learning test (hard), story recall test, and Benton's visual retention test findings revealed that patients with both amygdalohippocampal seizures and psychotic manifestations had more severe memory and attention impairments than did the patients with only seizures. Epilepsy: The Clinical Profile, Outcome, and Epilepsy-Related Psychosis.Purpose:This prospective study was conducted to evaluate the clinical profile and the prognostic factors in 1,000 epilepsy patients attending a tertiary care hospital from the year 1996 to 2001.Methods:The evaluation in all cases included clinical assessment, intelligence testing with the Stanford–Binet scale, metabolic workup, EEG, and computed tomography (CT) scan. Magnetic resonance imaging (MRI) and MR angiography (MRA) were done in selected patients. Patients were classified as per the International League Against Epilepsy (ILAE) classification and were followed up with the primary end point of a 1-year seizure-free period. Epilepsy-related psychosis was included as a study parameter in the final 3 years of the study period (500 patients). The psychoses were classified into postictal (immediately after seizures, distinct from the delirious, confusional state after seizures), interictal (with a lucid interval of normal mentation of≥24 h between seizure and psychosis), and chronic psychosis (of>3 months' duration, present all the time). Statistical analysis was done with aχ2 test wherever relevant.Results:The ages of the patients ranged from 7 months to 74 years, with a mean of 30± 8 years; 55% of them were male patients. Of the cases, 59% had localization-related epilepsy, whereas 41% had generalized epilepsy. Myoclonic epilepsy was seen in 5%, and absence seizures, in 3%. On analyzing the etiology of seizures, 66% were cryptogenic or idiopathic, 16% had neurocysticercosis, 8% had tuberculosis, 3% were postinfective, 3% had a vascular etiology, 2% had congenital abnormalities, and 2% were posttraumatic. Twelve (2.4%) patients were diagnosed as epilepsy-related psychosis, of whom eight were male patients. The majority (seven of 12) had complex partial seizures. Postictal psychosis was diagnosed in four patients; seven had acute interictal psychosis, and one patient had chronic psychosis. The interictal and chronic psychoses were schizophreniform, whereas the postictal psychoses were nonspecific. EEG showed a temporal lobe focus in all seven of the complex partial seizures with psychosis and an extratemporal focus in three patients. Two of the patients had normal EEGs. Neuroimaging abnormalities seen in 10 patients included gliosis (three), calcified granulomas (three), medial temporal sclerosis (two), and nonspecific findings (two). Two patients had normal imaging studies.Conclusions:No significant difference was seen in seizure control between the subgroups of patients with generalized and localization-related epilepsy. Our results are in agreement with the recent studies that suggest that the types and causes of seizures are not significantly related to the seizure control. The most predictive factors for good outcome were younger age (p<0.05) and good intellectual development (p<0.05). Earlier studies found 0.5–9% of patients with epilepsy to have epilepsy-related psychosis. Epilepsy-related psychosis was seen in 2.4% of our patients. This factor should be kept in mind by the caregivers of patients with epilepsy. Occupational Ability of Patients with Intractable Epilepsy.Purpose:To examine the occupational ability including interpersonal skills of patients with intractable epilepsy and to identify factors relevant for employment.Methods:Forty-eight patients (36 men, 12 women) with intractable epilepsy were studied. The mean age was 26.6 years (range, 18–49). Average IQ by Wechsler Adult Intelligence Scale–Revised was 61.4 (range, 38–95). Epilepsy diagnoses were symptomatic partial epilepsy, 41; symptomatic generalized epilepsy, six; and idiopathic generalized epilepsy, one. Seizure types were generalized tonic–clonic seizure, 13; complex partial seizure, 29; simple partial seizure, 11; and other seizures, 10. Twenty-one patients had more than one seizure per week. Nineteen patients had seizures with falling that might cause injury. We evaluated the occupational abilities of the patients through observation during occupational therapy and by vocational aptitude tests. At the same time, their employment status 6 to 18 months after leaving the hospital was surveyed. We then compared the abilities of employed patients (Employed) with those of unemployed patients (Unemployed). Fisher's exact test and Mann–WhitneyUtest were used for statistical analyses.Results:(a) Work habits, comprehension, practicality (quickness at work, workmanship), and interpersonal skills were evaluated as normal only in 40%, 6%, 10%, and 23%, respectively, of the patients through observation. The results of vocational aptitude test were generally low. Subsequent employment status was employed, 15; community workshop, five; day care, three; unemployed, 14, and others (including housewife, student), 11. (b) Intelligence scores (IQ; mean± S.D.) were 63.8± 11.1 in the Employed and 63.8± 16.7 in the Unemployed (NS). Comprehension and practicality were evaluated as normal in 13% of the Employed and none of the Unemployed (NS). Overall work habits were evaluated as normal in 67% of the Employed and 7% of the Unemployed (p<0.01). The subitem“asking therapists, greeting” was evaluated as sufficient in 80% of the Employed and 21% of the Unemployed (p<0.01). Interpersonal skills were evaluated as normal in 53% of the Employed and none of the Unemployed (p<0.01); 13% of the Employed and 79% of the Unemployed had a tendency to be isolated from others (p<0.01). As for vocational aptitude tests, the Employed performed better in tests of motor coordination, skilled finger movements, and sorting coins than the Unemployed (p<0.05). Concerning seizure control, none of the Employed and 29% of the Unemployed had seizures with falling during the daytime (NS).Conclusions:Good seizure control, preserved work habits, good interpersonal skills, and skilled motor coots with intractable epilepsy. [ABSTRACT FROM AUTHOR]

Objective: Although Ireland has one of the highest levels of well‐being in Europe, having a health condition has been found to have a direct negative impact. The aim of this study is to evaluate the current situation and the experiences of patients with epidermolysis bullosa (EB), a rare genetic skin disease, and their relatives living in Ireland, with a focus on burdens and helpful practices. Methods and Measures: In a mixed‐methods design, a series of standardised questionnaires were combined with open‐ended questions. Via an online survey, data from n = 59 EB patients and relatives of EB patients living in Ireland were collected. Results: EB affects both the patients and their relatives. Burdens were found in relation to the visibility of EB, the degree of severity, the current health status, reduced mobility, the financial impact of EB, the psychosocial impact and personal and social resources. The paper also analyses existing resources and highlights opportunities for support and needs of improvement. Conclusion: Quality of life with EB is influenced by somatic symptoms and the psychosocial burden. Individual helpful practices in dealing with this rare disease can be considered as mediators, but they need to be supported by structural and healthcare improvements. Patient or Public Contribution: The perspective of EB patients, their relatives and EB experts were taken into account in the development of the study design via two feedback loops with the EB patient organisations DEBRA Ireland and DEBRA Austria. The design was adapted accordingly. Additionally, by including open‐ended questions, patients and relatives could contribute their individual perspectives and add insights into their lives with EB that might not have been captured with the structured online survey alone. [ABSTRACT FROM AUTHOR]

A Case of Myoclonic Absence Epilepsy with Rightward Head Turning.Case Report:A 4-year-old girl born after full-term, uneventful gestation had myoclonic absence epilepsy with rightward head turning. Her motor and mental development was normal. Her grandfather had an episode of generalized seizure without fever at age 1 year. She had a febrile convulsion at age 10 months. At age 13 months, she had a generalized tonic–clonic seizure (GTCS) without fever. Between ages 13 and 17 months, she had five episodes of GTCSs, but did not receive anticonvulsants because of normal interictal EEG during sleep. She had no seizure during the subsequent 12 months despite no medication. At age 2 years 5 months, GTCSs recurred, and she had three episodes of falling attacks. Sleep EEG showed a normal background with a few spikes in the right frontal area. Treatment with carbamazepine was started. After treatment, she had no convulsive seizures except two episodes of loss of consciousness for a few seconds. Interictal EEG during sleep at age 3 years 3 months showed diffuse irregular polyspike-and-wave discharges. At age 3 years 8 months, she had myoclonic jerking. The myoclonic jerking lasted for 1–2 s and increased in frequency and duration after 2 months. The seizures were characterized by rhythmic myoclonic jerks of shoulders and arms and turning of the eye/head to the right. The seizure duration was 7–8 s. The seizures had abrupt onset and cessation. Ictal EEG showed bilateral, symmetrical, and synchronous 3-Hz spike-and-wave discharges. Brain magnetic resonance imaging (MRI) was normal. Her developmental quotient was 97. The seizures were controlled with high-dose valproic acid and ethosuximide. Interictal EEG at age 4 years 1 month was normal.Discussion:Myoclonic absence epilepsy (MAE) was first described by Tassinari et al. as a rare epileptic syndrome. According to their report, the prognosis for MAE was less favorable than that for pyknolepsy, often with mental deterioration, and possible evolution to other types of epilepsy. They also reported head and body deviation in some patients. The present case had myoclonic absence with rightward head turning and benign outcome, including normal development. Gastaut reported that versive or circling epilepsy with bilateral 3-cps spike–waves represented a benign form of primary generalized epilepsy. Aguglia et al. reported the occurrence of versive or circling seizures in idiopathic generalized epilepsies. The present case demonstrated that unilateral or clearly asymmetrical manifestations may be observed in generalized epilepsy. The Features of Localization-Related Epilepsy in Periventricular Leukomalacia.Purpose:Periventricular leukomalacia (PVL) is an important cause of chronic neurologic disability, such as spastic diplegia, delayed cognitive development, and epilepsy, in children born prematurely. Several reports have described the relationship between West syndrome and PVL, but the other types of epilepsy are not well documented. The aims of the present study were to determine whether the severity or outcome of epilepsy can be predicted from the degree of PVL.Methods:Seven epilepsy patients (two boys and five girls) born at 22–39 weeks of gestation and weighing 416–3,425 g were studied. Mean age at onset of epilepsy was 3 years 5 months (ranging from 1 year 5 months to 5 years 2 months). In all cases, the epileptic seizure was complex partial seizure[CPS;+secondarily generalized tonic–clonic convulsion (GTC)]. A diagnosis of PVL was made with magnetic resonance imaging (MRI) during late infancy, based on ventriculomegaly with an irregular margin accompanied by a periventricular abnormal high-intensity area on T2-weighted imaging. The subjects were divided into two groups according to the severity of PVL, based on MRI findings. Mild PVL (three cases) was defined as localized volume loss of periventricular white matter from around the trigonal zone to the occipital horns, and severe PVL (four cases) was diffuse volume loss extending to the frontal horns.Results:The three subjects in the mild-PVL group were term infants, and the other four were preterm infants. The onset age of CPSs was not significantly different between the two groups and was later than that for West syndrome previously reported. Interictal electroencephalogram (EEG) revealed spike discharges in occipital or parietal lesions in all seven cases. In the severe-PVL group, several spike discharges also were found in other lesions. On MRI findings, all cases had ventriculomegaly on both sides, and two of four cases with severe PVL had right-predominant ventriculomegaly, accompanied by uregyria in the right temporoparietal lesion on MRI.Conclusions:Regardless of the presence or absence of abnormal MRI findings of the cerebral cortex, all epilepsy cases with PVL had epileptic discharges in the occipital area on EEG. The severity of EEG and epileptic seizures may depend on the degree of PVL. Electroclinical Manifestations in a Patient with Vitamin B6 Dependency.Purpose:To identify the electroclinical manifestations in a patient with vitamin B6 dependency.Case Report:An 18-month-old female infant was first seen with hyperirritability and seizures. She was born at 39 gestational weeks. Her birth weight was 3,044 g, and Apgar scores were 9 at 1 min. No family history of epilepsy existed. She showed hyperirritability immediately after birth. During the neonatal period, hemorrhagic shock developed because of melena and intraventricular hemorrhage. At age 1 month, she was referred to us because of hyperirritability and intractable seizures. An interictal EEG revealed sporadic focal spikes. Simultaneous video-EEG monitoring demonstrated erratic myoclonia, serial spasms, partial seizures, or a combination of these seizures. A poorly organized slow high-voltage background with superimposed paroxysmal features was accompanied by erratic myoclonia. An ictal EEG showed a bilateral spiky high-voltage wave followed by voltage attenuation coinciding with the clinical spasms. An ictal EEG corresponding to a partial seizure had multiple foci. The seizures were resistant to antiepileptic drugs, including phenobarbital, carbamazepine, phenytoin, and lidocaine. At age 3 months, the seizures were controlled with vitamin B6. The diagnosis of vitamin B6 dependency was confirmed at age 12 months; seizures recurred 55 h after the discontinuation of vitamin B6 and again dramatically responded to intravenous vitamin B6.Conclusions:We report an infant with vitamin B6 dependency, who had a variety of seizures including erratic myoclonia, serial spasms, and partial seizures. Automatisms With Preserved Responses Without Verbal Responses in Temporal Lobe Epilepsy.Purpose:Automatisms with preserved responses (APRs) are observed in temporal lobe epilepsy (TLE) and have been regarded as a lateralizing sign of nondominant hemispheric origin. We report two patients with left TLE with APR without verbal responses, who had language dominance in the left and bilateral hemispheres respectively.Case Report:Case 1: A 19-year-old woman had intractable seizures consisting of lip smacking and right-hand fumbling. APRs were observed during seizures, but she could not show verbal responses. Magnetic resonance imaging (MRI) demonstrated left mesial temporal sclerosis. Video-EEG monitoring, positron emission tomography (PET), and single-photon emission computed tomography (SPECT) also suggested left mesial temporal lobe epilepsy. On Wada testing, her language dominance was bilateral. Functional MRI suggested that her sensory language area might be located in the right hemisphere and motor language area in the left hemisphere. Case 2: A 20-year-old woman had intractable seizures consisting of lip smacking and bilateral hand automatism. APRs were observed during attacks, but she could not answer in words. Left mesial temporal lobe epilepsy was documented with hippocampal sclerosis on MRI. Video-EEG monitoring, PET, and SPECT findings also suggested that the seizure originated in left temporal lobe. Her language dominance was in the left hemisphere, demonstrated by Wada testing and functional MRI.Conclusions:Our patients suggest that APRs without verbal response may occur in seizures originating in dominant or partially dominant temporal lobe. A Case with Absence Seizures of Frontal Lobe Origin: Simultaneous Video-EEG Findings.Absence seizures may be defined as a paroxysmal loss of consciousness of sudden onset and sudden end, which is associated with bursts of bilaterally synchronous 3-Hz spike-and-wave discharges recorded on the EEG. Usually, it is thought to be associated with a diffuse process affecting the brain, but absence seizures also are seen in some patients with localization-related epilepsy and accompanied by bursts of almost generalized 3-Hz spike-and-waves. We describe a 9-year-old boy first seen with absence seizures of frontal lobe origin, as recorded by a simultaneous video-EEG system.Case Presentation:At age 9 years, the patient experienced onset of absence seizures consisting of sudden arrest of speech and gesture, myoclonus of unilateral or bilateral angles of the mouth, alternation of consciousness, occasional simple automatisms, and brisk recovery of consciousness. Absence seizures occurred several times a day. He also experienced complex partial seizures 1 to 3 times a month with deviation of the head and eyes toward the left, elevation of left upper limbs, loss of consciousness, salivation, and tonic convulsion of left upper and lower limbs. Interictal EEG showed sporadic right frontal dominant high-voltage slow waves or spike-and-waves. There was no abnormal finding on brain magnetic resonance imaging. Interictal single-photon emission computed tomography indicated hypoperfusion of the dorsal and medial cortex of the right middle frontal lobe. Interictal positron emission tomography also indicated hypometabolic areas in the dorsal and medial cortex of the right frontal lobe, as well as in the right temporal and parietal cortex. Ictal EEG of a complex partial seizure could not be detected because of the low frequency of seizures. Simultaneous video-EEG recordings of 10 absence seizures revealed left frontal-dominant, diffuse high-voltage 3- to 3.5-Hz spike-and-wave complexes lasting several seconds. Partial seizures never preceded the absence seizures. Transverse bipolar montage recordings revealed that the first spike component of the spike-and-wave complexes of absence seizures always showed phase reversal on the right anterior temporal electrode. Subsequent components, however, showed phase reversal on the left anterior temporal electrode and continued at the end of seizures. EEG findings and neuroimaging studies suggested that the epileptogenic focus of absence seizures with myoclonus of the angles of mouth in this patient might have originated at the dorsal cortex of the right middle frontal lobe and immediately spread to the medial cortex of the frontal lobe. Both absence and complex partial seizures were well controlled with a combination of phenytoin and high-dose sodium valproate.Discussion:Pavone et al. reported the relation of absence seizures and the frontal lobe and concluded that the frontal maximum of the 3-Hz spike-and-wave pattern indicates frontal lobe involvement during absence seizures, including both prefrontal and frontomotor portions, and the prefrontal cortex is likely to account for the motor component of absence seizures such as myoclonic twitching. They also reported that this concept can be applied not only to the absence seizures occurring in generalized epilepsy but also to the rare cases with a primary frontal epileptogenic focus leading to absence seizures, as is in the present case. [ABSTRACT FROM AUTHOR]

Aims: Sewage treatment effluent with pharmaceutical residues is discharged into surface waters, raising societal concerns. The aim of this paper is to describe the Dutch chain approach on medicinal residues in water that has been implemented by the Dutch government. We show how stakeholders from both the health and water sectors have got actively involved. Within this chain approach, source measures as well as end‐of‐pipe measures are identified and, where feasible and effective, implemented. Methods: Descriptive paper on the Dutch chain approach. Results: Getting the water and health care sectors to talk with each other instead of about each other was the key accomplishment. Comprehension of each other's viewpoints, terminology, policy goals and span of control, was pivotal in setting shared goals, creating perspective about possible measures and actually taking (joint) action. Together, stakeholders agreed to act within their own possibilities, without pointing at others, and to focus on pragmatic measures. In this article, we provide examples of measures taken, pilot projects performed, and of measures that were not implemented. Besides this, we discuss the most important barriers encountered during this process and how they were overcome. Conclusion: The issue of pharmaceuticals in the environment is a wicked problem, which makes it necessary to work together with many stakeholders on possible solutions, avoiding paralysis by complexity. Most importantly, stakeholders need to invest in mutual understanding, keep an open communication, and feel invited to bring in solutions for their part of the chain. [ABSTRACT FROM AUTHOR]

In comparison to the efforts required to bring a new drug or formulation to the clinic, bestowing a name on a medicine is relatively simple. However, if the name we choose causes confusion—by making its contents ambiguous or if it is too alike another drug—it can precipitate clinical errors. This prompted the World Health Organization to set up the International Nonproprietary Naming Committee in the 1970s to select unambiguous names for drugs. Unfortunately, multidrug products—which are becoming increasingly popular—do not fall under the remit of conventional International Non‐proprietary Nomenclature. We have identified 26 combination formulations that have been historically named with the co‐drug format in the United Kingdom. Most of them have also been prescribed in the United Kingdom in the past year, and although several of them are not prescribed very often, 11 were prescribed more than 2000 times. In this paper, we have explored the literature to identify prescribing errors with co‐drug products and found several idiosyncrasies that have caused drug errors in the past. We advocate for a standard nomenclature (state the international nonproprietary name [INN] of each component followed by dose information in the x + y format) for these products on the box and in prescribing resources. We hope that this will enhance clarity and safety during prescribing and administration, particularly for high‐volume drugs like paracetamol + codeine (co‐codamol), amoxicillin + clavulanic acid (co‐amoxiclav) and trimethoprim + sulfamethoxazole (co‐trimoxazole). [ABSTRACT FROM AUTHOR]

The article invites contributions in all fields of experimental pharmacology including studies on normal human subjects to be published in "British Journal of Pharmacology". The work should have a direct bearing on drugs and their actions. Papers describing the discovery and characteristics of new chemically defined compounds are welcomed.

The present study is an attempt to evaluate the in vitro anti‐inflammatory and in silico anticancer potentials of the plant Cassia auriculata (CA). The aerial parts of CA were subjected to solvent extraction, and the extracts were fractionised by gas chromatography and mass spectrometry analysis for its phytochemical content. The antiinflammatory activity of the extracts were confirmed by the IC50 value of 125.02 µg/ml for red blood cell membrane stabilisation and 195.7 µg/ml for inhibition of protein denaturation activity. The interaction of bioactive compounds of CA ethanol extract with target protein was predicted through molecular docking studies, serine/threonine–protein kinase B (AKT1), responsible for development and progression of lung cancer using AutoDock tools. Extensive studies have been carried out on a range of kinase inhibitors targeting Akt, but obtaining promising results is a challenge yet due to its toxicity and resistance issues. Yohimbine, undecanoic acid 10‐methyl‐ethyl ester and chrysin significantly bind to the target protein with least binding energy. Hence, the present paper establishes the anti‐inflammatory and anticancer capacities of CA ethanol extract as an alternative to the existing therapeutic approach to inflammation and cancer through a systematic in vitro and in silico approaches supplementing the findings. [ABSTRACT FROM AUTHOR]

The progress the Internet has experienced in recent years has brought about huge changes and social transformation in all aspects of our lives. One such aspect greatly impacted has been our health, where we can talk about the existence of an ‘Internet of Medical Things’. Amid this digital drift, we have seen the development of pharmaceutical drugs that provide information to patients and their attending healthcare teams concerning medication, doses ingested, and time of ingestion. These are digital pills or digital medication. In this context, the purpose of my paper is to analyze the ethical and legal impact of digital medication, further analyzing the implications concerning the right of service users to make decisions over their own health in Spain. [ABSTRACT FROM AUTHOR]

Upscaling of medication adherence interventions to routine care is still challenging. This realist theory‐inspired review aimed to assess which intervention aspects are potentially important for the scalability of effective cardiovascular disease (CVD) medication adherence interventions and how they are reported in effectiveness studies. A total of 4097 articles from four databases were screened of which ultimately 31 studies were included. Relevant information on scalability was extracted using a theoretic framework based on the scalability assessment tool used in the QUALIDEC study for the following domains: (i) innovation, (ii) implementers and patients, (iii) adopting organizations and health system, and (iv) socio‐political context. Extracted articles were analysed for themes and chains of inference, which were grouped based on commonality and source of evidence to form new hypotheses. Six different domains relevant for scalability of adherence interventions were identified: (1) Complexity of the intervention; (2) training; (3) customization of the intervention; (4) drivers of the intervention; (5) technical interventions; and (6) stakeholder involvement. These six domains might be useful for the development of more scalable interventions by bridging the gap between research and practice. Data relevant for scalability is not well reported on in effectiveness trials for CVD medication adherence interventions and only limited data on scalability has been published in additional papers. We believe the adoption and reach of effective CVD medication adherence interventions will improve with increased awareness for the necessity of scalability in all phases of intervention development. [ABSTRACT FROM AUTHOR]

Background: As people age, they are more likely to develop multiple long‐term conditions that require complicated medicine regimens. Safely self‐managing multiple medicines at home is challenging and how older people can be better supported to do so has not been fully explored. Aim: This study aimed to identify interventions to improve medicine self‐management for older people living at home and the aspects of medicine self‐management that they address. Design: A rapid review was undertaken of publications up to April 2022. Eight databases were searched. Inclusion criteria were as follows: interventions aimed at people 65 years of age or older and their informal carers, living at home. Interventions needed to include at least one component of medicine self‐management. Study protocols, conference papers, literature reviews and articles not in the English language were not included. The results from the review were reported through narrative synthesis, underpinned by the Resilient Healthcare theory. Results: Database searches returned 14,353 results. One hundred and sixty‐seven articles were individually appraised (full‐text screening) and 33 were included in the review. The majority of interventions identified were educational. In most cases, they aimed to improve older people's adherence and increase their knowledge of medicines. Only very few interventions addressed potential issues with medicine supply. Only a minority of interventions specifically targeted older people with either polypharmacy, multimorbidities or frailty. Conclusion: To date, the emphasis in supporting older people to manage their medicines has been on the ability to adhere to medicine regimens. Most interventions identify and target deficiencies within the patient, rather than preparing patients for problems inherent in the medicine management system. Medicine self‐management requires a much wider range of skills than taking medicines as prescribed. Interventions supporting older people to anticipate and respond to problems with their medicines may reduce the risk of harm associated with polypharmacy and may contribute to increased resilience in the system. Patient or Public Contribution: A patient with lived experience of medicine self‐management in older age contributed towards shaping the research question as well as the inclusion and exclusion criteria for this review. She is also the coauthor of this article. A patient advisory group oversaw the study. [ABSTRACT FROM AUTHOR]

Aim: To determine the efficacy of fenfluramine on seizure frequency in patients with Sunflower syndrome. Secondary endpoints were changes in electroencephalogram (EEG) characteristics, cognitive functioning, executive functioning, and quality of life. Method: In this open‐label study, patients underwent a 4‐week baseline period, followed by 3 months of treatment. An oral solution of fenfluramine was administered twice daily for 3 months. The dose was titrated up to a maximum dose of 0.7mg/kg/day or 26mg/day. Cardiac safety was monitored by transthoracic echocardiogram and electrocardiogram. EEGs, abbreviated neuropsychological testing, and questionnaires were administered before starting the study medication and again at the end of the treatment period. Results: Ten patients (eight females, two males; mean age 13y 4mo [SD 4y 11mo], range 7–24y) were enrolled in the study. Nine of the 10 patients completed the core study, eight of whom met the primary endpoint. There were no observations of cardiac valvulopathy or pulmonary hypertension during the study. Interpretation: Treatment with low‐dose fenfluramine resulted in a clinically significant reduction in seizure frequency, including hand‐waving episodes. Fenfluramine may be an effective treatment option for patients with Sunflower syndrome. What this paper addsNine patients with Sunflower syndrome were treated with fenfluramine.Eight patients were responders, displaying a ≥30% reduction in seizure activity.Six patients experienced a ≥70% reduction in hand‐waving episodes.Improvements on electroencephalogram were observed after treatment with fenfluramine.None of the patients developed evidence of cardiac valvulopathy or pulmonary hypertension. What this paper adds: Nine patients with Sunflower syndrome were treated with fenfluramine.Eight patients were responders, displaying a ≥30% reduction in seizure activity.Six patients experienced a ≥70% reduction in hand‐waving episodes.Improvements on electroencephalogram were observed after treatment with fenfluramine.None of the patients developed evidence of cardiac valvulopathy or pulmonary hypertension. [ABSTRACT FROM AUTHOR]

Aim: To assess the effectiveness and safety of levetiracetam when used as first‐line treatment of neonatal seizures. Method: Four electronic databases, Medline, Embase, Web of Science, and ClinicalTrials.gov were systematically searched from inception until 20th November 2020. Randomized controlled trials (RCTs) and observational studies that included neonates born preterm and term were eligible for inclusion. The primary outcome measure was levetiracetam effectiveness, defined as seizure cessation within 24 hours of starting treatment. Secondary outcomes included short‐term adverse events, mortality before discharge, and long‐term neurodevelopmental outcomes. Results: Fourteen studies assessing 1188 neonates were included: four RCTs, three observational trials with phenobarbital as the control arm, and seven observational studies of levetiracetam with no control arm. Pooled efficacy of levetiracetam from observational studies was 45% (95% confidence interval [CI] 34–57%) (GRADE – very low). Meta‐analysis of RCTs evaluating levetiracetam versus phenobarbital showed that both were equally effective (risk ratio [95% CI] 0.6 [0.30–1.20]) (GRADE – very low). Levetiracetam resulted in a lower risk of short‐term adverse events compared to phenobarbital (risk ratio [95% CI] 0.24 [0.06–0.92]) (GRADE – moderate). Interpretation: Very low certainty of evidence suggests levetiracetam might not be more effective than phenobarbital. Moderate certainty of evidence indicates levetiracetam is associated with a lower risk of adverse events. Future trials on neonatal antiseizure medication therapy should include continuous electroencephalogram (EEG) monitoring as standard of care and enrol a homogenous population with similar seizure aetiology. What this paper addsLevetiracetam is effective in 45% of neonatal seizures.Levetiracetam might not be more effective than phenobarbital.Levetiracetam is likely to be safer than phenobarbital.Evidence available is limited and of very low certainty. What this paper adds: Levetiracetam is effective in 45% of neonatal seizures.Levetiracetam might not be more effective than phenobarbital.Levetiracetam is likely to be safer than phenobarbital.Evidence available is limited and of very low certainty. [ABSTRACT FROM AUTHOR]

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Objective: To formalize comparative interrupted time series (CITS) using the potential outcomes framework; compare two version of CITS--a standard linear version and one that adds postperiod group-by-time parameters--to two versions of difference-in-differences (DID)--a standard version with time fixed effects and one that adds group-specific pretrends; and reanalyze three previously published papers using these models. Data Sources: Outcome data for reanalyses come from two counties' jail booking and release data, Medicaid prescription drug rebate data from the Centers for Medicare and Medicaid Services (CMS), and acute hepatitis C incidence from the Centers for Disease Control and Prevention. Study Design: DID and CITS were compared using potential outcomes, and reanalyses were conducted using the four described pre--post study designs. Data Collection/Extraction Methods: Data from county jails were provided by sheriffs. Data from CMS are publicly available. Data for the third reanalysis were provided by the authors of the original study. Principal Findings: Though written differently and preferred by different research communities, the general version of CITS and DID with group-specific pretrends are the same: they yield the same counterfactuals and identify the same treatment effects. In a reanalysis with evidence of divergent preperiod trends, failing to account for this in standard DID led to an 84% smaller effect estimate than the more flexible models. In a second reanalysis with evidence of nonlinear outcome trends, failing to account for this in linear CITS led to a 28% smaller effect estimate than the more flexible models. Conclusion: We recommend detailing a causal model for treatment selection and outcome generation and the required counterfactuals before choosing an analytical approach. The more flexible versions of DID and CITS can accommodate features often found in real data, namely, nonlinearities and divergent preperiod outcome trends. [ABSTRACT FROM AUTHOR]

Aim: To provide an overview of responsibilities and tasks of nurses in pharmaceutical care. Design: Scoping review. Methods: Two databases were systematically searched (MEDLINE and Scopus) for recent original research papers concerning nurses' responsibilities and tasks in pharmaceutical care. The definition of responsibility was based on literature, moral and ethical discussions. Existing responsibilities and tasks beyond preparation and administration of medication were collected and synthesized. This main study outcome was extracted from titles and abstracts only. Results were reported in accordance with PRISMA‐ScR guidelines. Results: Of the 3,805 titles and abstracts reviewed, 453 abstracts were included. A total of seven responsibilities were identified: (a) management of therapeutic and adverse effects of medication, (b) management of medication adherence, (c) management of patient medication self‐management, (d) management of patient education and information about medication, (e) prescription management, (f) medication safety management and (g) (transition of) care coordination. Within these responsibilities, all tasks performed by nurses were described. [ABSTRACT FROM AUTHOR]

LINKED CONTENT: This article is linked to Everhov et al paper. To view this article, visit https://doi.org/10.1111/apt.17675 [ABSTRACT FROM AUTHOR]

Objectives: Drug treatment for children with epilepsy should, ideally, be governed by evidence from adequate and well‐controlled clinical studies. However, these studies are difficult to conduct, and so direct evidence supporting the informed use of specific drugs is often lacking. The Research Roundtable for Epilepsy (RRE) met in 2020 to align on an approach to therapy development for focal seizures in children age 1 month <2 years of age. Methods: The RRE reviewed the regulatory landscape, epidemiology, seizure semiology, antiseizure medicine pharmacology, and safety issues applicable to this population. Results: After reviewing evidence, the conclusion was that pediatric efficacy trials would be impracticable to conduct but a waiver of the regulatory requirement to conduct any study would lead to an absence of information to guide dosing in a critical population. Review of available data and discussion of RRE attendees led to the conclusion that the requirements for extrapolation of efficacy from older children down to infants from age 1 month to <2 years old appeared to be met. After the RRE, the US Food and Drug Administration (FDA) approved brivaracetam for use in children with focal epilepsy above the age of 1 month in August 2021 and lacosamide in October 2021, both based on the principle of extrapolation from data in older children. Significance: These recommendations should result in more rapid accessibility of antiseizure medications for infants. [ABSTRACT FROM AUTHOR]

Introduction: British South Asians have a higher prevalence of overweight and obesity than the wider population. Bradford (UK), with its high Pakistani presence and levels of economic deprivation, has exceptionally high instances, especially in deprived areas where many Pakistanis reside. British Pakistani women in Bradford are more likely to be overweight and obese. There is uncertainty on how these women can be aided to manage their weight. Therefore, the objective of this study was to explore the obesity concerns of Pakistani women living in deprived inner‐city areas of Bradford. Methods: Three focus groups interviews were carried out with 23 Pakistani women living in deprived areas of Bradford. Data were analysed thematically. Results: This exploratory study identified a wide range of concerns that women had around managing their weight. Participants disclosed distrust in information given around medication, conflicting dietary information and reported low levels of trust in women‐only organized physical activities. Cultural barriers were identified, which included the gender role of the woman, the lack of culturally appropriate dietary advice, cultural misunderstandings of what constitutes a healthy diet and healthy weight, the lack of culturally suitable exercise facilities and conforming to family and community expectations. Other concerns were language barriers around a lack of understanding, the inability to read Urdu and reliance on others to translate information. Conclusion: These findings have implications for researchers, local authorities, policy makers and others with an interest in reducing the rates of obesity in this population. Recommendations include training health practitioners to be culturally aware of the diet and eating practices of this community, exploring different ways to support socially isolated women to be more physically active at home, addressing physical activity and diet misconceptions and designing obesity management information materials appropriate for a range of literacy levels. Patient or Public Contribution: Public contributors were involved in the development of the interview guide and design of the research. A pilot focus group with participants not included in the present paper was used to help test and refine the focus group questions. Interview transcripts were member checked by participants, and participants assisted with data analysis. [ABSTRACT FROM AUTHOR]

Aims: A key reason for the failure of antituberculosis (anti‐TB) treatment is missed doses (instances where medication is not taken). Adverse drug reactions (ADRs) are 1 cause of missed doses, but the global evidence, their relative contribution to missed doses vs. other causes, the patterns of missed doses due to ADRs and the specific ADRs associated with missed doses have not been appraised. We sought to address these questions through a scoping review. Methods: MEDLINE, Embase and Web of Science were searched on 3 November 2021 using terms around active TB, missed doses and treatment challenges. Studies reporting both ADR and missed dose data were examined (PROSPERO: CRD42022295209). Results: Searches identified 108 eligible studies: 88/108 (81%) studies associated ADRs with an increase in missed doses; 33/61 (54%) studies documenting the reasons for missed doses gave ADRs as a primary reason. No studies examined patterns of missed doses due to ADRs; 41/108 (38%) studies examined associations between 68 types of ADR (across 15 organ systems) and missed doses. Nuance around ADR‐missed doses relations regarding drug susceptibility testing profile and whether the missed doses originated from the patient, healthcare professionals, or both were found. Conclusion: There is extensive evidence that ADRs are a key driver for missed doses of anti‐TB treatment. Some papers examined specific ADRs and none evaluated the patterns of missed doses due to ADRs, demonstrating a knowledge deficit. Knowing why doses both are and are not missed is essential in providing targeted interventions to improve treatment outcomes. [ABSTRACT FROM AUTHOR]

A balanced approach using an integrated combination of strategies, namely, demand reduction, supply reduction and harm reduction, was suggested to be implemented in a balanced way to the policy vision of a South Africa 'free of substance abuse'. Responding on the call for a comprehensive review of the National Drug Master Plan 2013–2017 to ensure consistency in policy approach, this article explores the integrative propositional analysis (IPA)‐based analysis to evaluate 'how systemic' and integrated were the policy strategies applied. The analysis draws insights from the internal consistency of the policy and provides complementary evidence on the systemic breakdown of the policy, which correlates with previous studies. The findings are indicative of the usefulness of the IPA‐based tools to more pragmatically develop policy that better reflects the systemic/integrated relationship of the three strategies based on their conceptual systemic integrity. This research has implications for interdisciplinary scholars and practitioners, of policy and theory. [ABSTRACT FROM AUTHOR]

Aim: The White Paper on Crime 2019 from the Japanese Ministry of Justice reported that the percentage of crimes committed by people with mental disabilities was only 1.0%. In contrast, the findings of a statistical survey of correctional facilities reported that 15.1% of the prisoners were diagnosed with a mental illness. This study aimed at clarifying the relationship between mental illness and crime among suspects in a detention house and explaining this large gap. Methods: Criminal suspects who were newly admitted in the Gifu detention house in Japan were eligible for the study. The status of psychotropic drug use was investigated, and its relationship with age, sex, offense history, and type of crime was analyzed. Newly prescribed medications in detention houses or police stations were excluded. Results: In total, 26.5% of the residents in a detention house used psychotropic drugs. The psychotropic drug use rate was 16.7% (excluding the sleeping pill use rate). The use rates of sleeping pills, anxiolytics, antidepressants, and antipsychotics were 22.6%, 11.1%, 3.0%, and 9.6%, respectively. Psychotropic drug use was high in illicit drug users and low in suspects for immigration violence. Psychotropic drug use was higher among female suspects, suspects in their 40s and 50s, and suspects with a multiple crime history. Anxiolytic (17.0%) and antipsychotic (11.9%) use rates were high among suspects for violence. Conclusion: In total, 26.5% of the subjects used psychotropic drugs. Psychotropic drug use was high in illicit drug users and low in suspects for immigration violence. [ABSTRACT FROM AUTHOR]

Introduction: There is increasing demand for effective sleep health and promotion strategies that are accessible to the general population. Sleep hygiene has traditionally focused on promoting behaviours that facilitate good sleep and avoiding behaviours that interfere with sleep. However, simply following good sleep hygiene practices has proven largely ineffective in clinical samples suffering insomnia, and effectiveness of these recommendations in the general population has also been questioned. One reason for this may be the lack of consideration with respect to interactions between these different factors, as many elements determine a 'good' and a 'bad' night's sleep. Methods: The present paper utilised a mixed methods approach using a combination of framework approach thematic analysis (qualitative) and the number of mentions of different characteristics defining a good and bad night's sleep (quantitative) in participants' (N = 282 (157 females), mean age 27 years) accounts of their last good and bad night's sleep, and how (if at all) alcohol or drugs played a role. Results: We found that both good and bad night's sleep were influenced by multiple factors and that often the same factors were implicated in both. A significant number of participants described elements of the sleep episode (e.g., timing pre- vs. postmidnight, consistency of routine, sleep onset latency, sleep environment), or other behavioural or environmental factors (e.g., alcohol or drug use, mood, food consumed prior to sleep) they perceived were involved in their experience of a good or bad night's sleep. Conclusions: Rather than isolating factors as is typically done in sleep hygiene principles, or viewing these factors as discrete and/or having predictable effects on sleep, it is important to examine how these factors coalesce to shape a good and bad night's sleep. [ABSTRACT FROM AUTHOR]

LINKED CONTENT This article is linked to Taxonera et al paper. To view this article, visit https://doi.org/10.1111/apt.15804 [ABSTRACT FROM AUTHOR]

As authors of two papers proposing the "old" algorithm to assess the therapeutic innovation of the medicines approved by the EM(E)A between 1995 and 2003,1,2 we have read with great interest and curiosity the paper by Filomena Fortinguerra et al. entitled "Using GRADE methodology to assess innovation of new medicinal products in Italy."3 These authors rightly write that the Italian Medicines Agency (AIFA) was the first regulatory body to introduce a method for acknowledging and ranking the therapeutic innovation when it adopted our algorithm in 2007.4 As former chairman (NM) and member (DM), on behalf of AIFA, of the 2007-AIFA/Industry working group commissioned to support such adoption, we had to arrange a few significant changes on the initial published algorithm. Of course, we fully admit the right of AIFA to adopt new and perhaps more advanced tools for assessing therapeutic innovation, but at the same time, we claim the value of our algorithm methodology, which has received significant acknowledge in the literature. [Extracted from the article]

People with intellectual disabilities (PwID) have a bidirectional relationship with epilepsy. Nearly 25% of PwID have seizures and 30% people with epilepsy are thought to have a significant intellectual impairment. Furthermore, 70% of PwID are thought to have treatment‐resistant epilepsy. In the United Kingdom, antiseizure medications (ASMs) are the second most widely prescribed psychotropic agent for PwID. However, it is unclear what the current evidence and patterns is on current prescribing of ASMs, including when and how a case is made to withdraw them. A narrative review along with an analysis of large‐scale NHS Digital published data (2015–2020) on several aspects of ASM prescribing by general practices for PwID was undertaken. The review results and data analysis are consolidated and presented as 11 themes to provide a comprehensive overview of the study topic. Recent studies estimate that one‐third and one‐fifth of PwID are prescribed ASMs. A history of epilepsy is seen as the primary prescribing reason; however, often it is a legacy, and the indication is no longer clear. The proportion receiving ASMs continues to rise with age. This pattern of use does not correlate well with seizure onset. There are limited data on de‐prescribing ASMs in PwID. The study population heterogenicity, associated polypharmacy, multimorbidity and higher sudden unexpected death in epilepsy risks are outlined. Suggestions are made from available evidence for improving prescribing practices for PwID and seizures, and key areas for further research in this complex clinical area are outlined. [ABSTRACT FROM AUTHOR]

The United States spends nearly 1/5th of its GDP on healthcare. Yet, to achieve value‐based care, the Economist describes the US healthcare system as handicapped by multiple, disparate silos that prevent the organization and sharing of data. This paper explores the current state of clinical oncology drug research and its relationship to value‐based cancer care. Clinical Chemotherapy Pathways are proposed as a unifying structure to bring together disparate sources of data to increase value. [ABSTRACT FROM AUTHOR]

Background: Patient and public involvement and co‐production are widely used, but nevertheless contested concepts in applied health research. There is much confusion about what they are, how they might be undertaken and how they relate to each other. There are distinct challenges and particular gaps in public involvement in alcohol research, especially when the study focus is on health matters other than alcohol dependence. Objective: To explore how patient and public involvement and co‐production have been interpreted and applied within a multi‐disciplinary research programme in the development of a complex intervention on alcohol and medicine use in community pharmacies. Design: The paper presents the authors' critical reflection on a grounded example of how public involvement concepts have been translated into practice in the intervention development phase of a publicly funded research programme, noting its impact on the programme to date. Discussion: Co‐production adds another layer of complexity in the development of a complex intervention. The research planning requirements for publicly funded research circumscribe the possibilities for co‐production, including impacting on the possibility of stability and continuity over time. [ABSTRACT FROM AUTHOR]

The risk of postoperative bleeding is a daily concern for many general dental practitioners. A thorough medical and medication history must be taken to consider all risk factors, particularly drugs, that contribute to bleeding risk. While the risk from drugs such as aspirin, warfarin and clopidogrel are well known, the extent to which new antiplatelet agents and direct oral anticoagulants affect bleeding risk is less well understood. In addition, there are drugs other than antithrombotics, such as antidepressants and complementary medicines that also impair haemostasis. The aim of this paper is to provide dentists with an updated overview of the drugs commonly encountered in general dental practice that can contribute to a patient's postoperative bleeding risk. [ABSTRACT FROM AUTHOR]

Spinal muscular atrophy (SMA) is the most common genetic disease that causes infant mortality. Its treatment and prevention represent the paradigmatic example of the ethical dilemmas of 21st‐century medicine. New therapies (nusinersen and AVXS‐101) hold the promise of being able to treat, but not cure, the condition. Alternatively, genomic analysis could identify carriers, and carriers could be offered in vitro fertilization and preimplantation genetic diagnosis. In the future, gene editing could prevent the condition at the embryonic stage. How should these different options be evaluated and compared within a health system? In this paper, we discuss the ethical considerations that bear on the question of how to prioritize the different treatments and preventive options for SMA, at a policy level. We argue that despite the tremendous value of what we call 'ex‐post' approaches to treating SMA (such as using pharmacological agents or gene therapy), there is a moral imperative to pursue 'ex‐ante' interventions (such as carrier screening in combination with prenatal testing and preimplantation genetic diagnosis, or gene editing) to reduce the incidence of SMA. There are moral reasons relating to autonomy, beneficence and justice to prioritize ex‐ante methods over ex‐post methods. [ABSTRACT FROM AUTHOR]

Quantitative systems pharmacology (QSP) approaches have been increasingly applied in the pharmaceutical since the landmark white paper published in 2011 by a National Institutes of Health working group brought attention to the discipline. In this perspective, we discuss QSP in the context of other modeling approaches and highlight the impact of QSP across various stages of drug development and therapeutic areas. We discuss challenges to the field as well as future opportunities. [ABSTRACT FROM AUTHOR]

Population pharmacokinetic (PK) models are widely used to inform drug development by pharmaceutical companies and facilitate drug evaluation by regulatory agencies. Developing a population PK model is a multi‐step, challenging, and time‐consuming process involving iterative manual model fitting and evaluation. A tool for fully automatic model development (AMD) of common population PK models is presented here. The AMD tool is implemented in Pharmpy, a versatile open‐source library for pharmacometrics. It consists of different modules responsible for developing the different components of population PK models, including the structural model, the inter‐individual variability (IIV) model, the inter‐occasional variability (IOV) model, the residual unexplained variability (RUV) model, the covariate model, and the allometry model. The AMD tool was evaluated using 10 real PK datasets involving the structural, IIV, and RUV modules in three sequences. The different sequences yielded generally consistent structural models; however, there were variations in the results of the IIV and RUV models. The final models of the AMD tool showed lower Bayesian Information Criterion (BIC) values and similar visual predictive check plots compared with the available published models, indicating reasonable quality, in addition to reasonable run time. A similar conclusion was also drawn in a simulation study. The developed AMD tool serves as a promising tool for fast and fully automatic population PK model building with the potential to facilitate the use of modeling and simulation in drug development. [ABSTRACT FROM AUTHOR]

The motor impairments experienced by people with Parkinson's disease (PD) are exacerbated during memory‐guided movements. Despite this, the effect of antiparkinson medication on memory‐guided movements has not been elucidated. We evaluated the effect of antiparkinson medication on motor control during a memory‐guided reaching task with short and long retention delays in participants with PD and compared performance to age‐matched healthy control (HC) participants. Thirty‐two participants with PD completed the motor section of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS‐UPDRS III) and performed a memory‐guided reaching task with two retention delays (0.5 s and 5 s) while on and off medication. Thirteen HC participants completed the MDS‐UPDRS III and performed the memory‐guided reaching task. In the task, medication increased movement velocity, decreased movement time, and decreased reaction time toward what was seen in the HC. However, movement amplitude and reaching error were unaffected by medication. Shorter retention delays increased movement velocity and amplitude, decreased movement time, and decreased error, but increased reaction times in the participants with PD and HC. Together, these results imply that antiparkinson medication is more effective at altering the neurophysiological mechanisms controlling movement velocity and reaction time compared with other aspects of movement control. [ABSTRACT FROM AUTHOR]

Camera‐based Driver Monitoring Systems (DMS) have the potential to exploit eye tracking correlates of alcohol intoxication to detect drunk driving. This study investigates how glance, blink, saccade, and fixation metrics are affected by alcohol, and whether possible effects remain stable across three different camera setups, as well as when the driver is out‐of‐the‐loop during level 4 automated driving (Wizard‐of‐Oz setup). Thirty‐five participants drove on a test track first sober and then with increasing intoxication levels reaching a breath alcohol concentration (BrAC) of 1‰. Linear Mixed‐Effects Regression analyses showed that with increasing intoxication levels, eye blinks became longer and slower, glances and fixations became fewer and longer, and more attention was directed to the road area, at the expense of more peripheral areas. Fixation and blink metrics were more robust to changes in automation mode, whereas glance‐based metrics were highly context dependent. Not all effects of alcohol intoxication could be measured with all eye tracking setups, where one‐camera systems showed lower data availability and higher noise levels compared to a five‐camera system. This means that lab findings based on higher quality eye tracking data might not be directly applied to production settings because of hardware limitations. [ABSTRACT FROM AUTHOR]

We present a novel case of an urticaria multiforme‐type drug reaction to the new cystic fibrosis medication Trikafta (elexacaftor + tezacaftor + ivacaftor). Equipped with this information, clinicians may be more prepared to counsel and treat patients if they experience similar symptoms after beginning Trikafta. [ABSTRACT FROM AUTHOR]

LINKED CONTENT: This article is linked to Jølving et al paper. To view this article, visit https://doi.org/10.1111/apt.16578 [ABSTRACT FROM AUTHOR]

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Context The National Institute for Health and Care Excellence ( NICE) has an explicit mandate to include patient and public involvement in the appraisal of medicines to be available for funding on the NHS. NICE involves an appraisal committee who are required to take on board experiential evidence from patient experts alongside population-based evidence on clinical and cost-effectiveness when making a decision whether to fund a drug. Objective This paper considers how NICE Single Technological Appraisal ( STA) committees attempt to incorporate the views of patients in making decisions about funding medicines on the NHS. Methods A prospective design was employed to follow three pharmaceutical products involving three different appraisal committees. Three data collection methods were used: analysis of documentary evidence sent by NICE, non-participant unstructured observations of the open and closed sessions of meetings and qualitative interviews. Settings and participants Unstructured non-participant observations were carried out at nine STA meetings, and 41 semi-structured interviews were undertaken with committee members from NICE's STA committees, patient experts, analysts from NICE's project team and drug manufacturers. Results Our analysis showed how the committees displayed a preference for an ideal-type of patient representative, disagreement among the committee when weighing-up patient statements in the STA process and more pre-preparation support for patient involvement. Conclusions Although NICE has attempted to adopt an approach flexible to patients and carers through formal decision-making arrangements that incorporate patient views, nonetheless, the processes of the STAs can in fact undermine the very evidence collected from patient representatives. [ABSTRACT FROM AUTHOR]

Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Nowadays, the focus of diabetes treatment has switched from lowering the glucose level to preserving glycemic homeostasis and slowing the disease progression. The main pathophysiology of both type 1 diabetes and long‐standing type 2 diabetes is pancreatic β‐cell mass loss and dysfunction. According to recent research, human pancreatic β‐cells possess the ability to proliferate in response to elevated insulin demands. It has been demonstrated that in insulin‐resistant conditions in humans, such as obesity or pregnancy, the β‐cell mass increases. This ability could be helpful in developing novel treatment approaches to restore a functional β‐cell mass. Treatment strategies aimed at boosting β‐cell function and mass may be a useful tool for managing diabetes mellitus and stopping its progression. This review outlines the processes of β‐cell failure and detail the many β‐cell abnormalities that manifest in people with diabetes mellitus. We also go over standard techniques for determining the mass and function of β‐cells. Lastly, we provide the therapeutic implications of utilizing antidiabetic drugs in controlling the mass and function of pancreatic β‐cells. [ABSTRACT FROM AUTHOR]

Aim: To investigate changes in the clinical characteristics of patients who abused benzodiazepine receptor agonists (BZRA) or over‐the‐counter (OTC) drugs before and after COVID‐19 based on the 2018 and 2022 data of the "Nationwide Psychiatric Hospital (NPH) Survey on Drug‐related Psychiatric Disorders." Method: A total of 446 and 155 cases, and 435 and 273 cases, who mainly abused BZRAs or OTC drugs, respectively, were extracted from the database of the two NPH Surveys. Demographic variables, education, employment, criminal record, drug use during the previous year, psychiatric diagnosis, and types of abused drugs were compared between 2018 and 2022. Result: A comparison of BZRA abusers revealed a decreased number of users during the previous year and an increase in the comorbidity rate of other disorders (F3 and F4 in ICD‐10) in 2022. Etizolam, flunitrazepam, triazolam, and zolpidem were used most in both years, with an increase in zolpidem and a decrease in triazolam in 2022. A comparison of OTC drug abusers revealed a higher proportion of women and young patients in 2022. An increase in the comorbidity rate of F3 and F9 and a significant increase in the use of dextromethorphan products were observed in 2022, although codeine products were in the majority in both years. Conclusion: By comparing NPH Surveys before and after the COVID‐19 pandemic, both BZRA abusers and OTC drug abusers present complex pathologies, requiring tailor‐made treatment. The younger OTC drug abusers were particularly evident among women, and the abuse of dextromethorphan‐containing OTC drugs has increased alarmingly. [ABSTRACT FROM AUTHOR]

New advancements in nanocarrier technologies are revolutionizing the delivery of drugs through the skin, allowing for precise treatment with better absorption, stability, and bioavailability. This review investigates lipid and inorganic nanocarriers like liposomes, ethosomes, and inorganic nanoparticles and assesses their potential for delivering drugs through the skin. It emphasizes the mechanisms that enable controlled release and deeper skin penetration, which are crucial for ensuring effectiveness in clinical applications. The review synthesizes existing research, acknowledging that only few nanocarriers are successfully deployed in clinical settings. By offering a comprehensive overview, it sheds light on the progress and future obstacles to using nanocarriers for drug delivery through the skin. [ABSTRACT FROM AUTHOR]

Pulmonary fibrosis represents the final alteration seen in a wide variety of lung disorders characterized by increased fibroblast activity and the accumulation of substantial amounts of extracellular matrix, along with inflammatory damage and the breakdown of tissue architecture. This condition is marked by a significant mortality rate and a lack of effective treatments. The depositing of an excessive quantity of extracellular matrix protein follows the damage to lung capillaries and alveolar epithelial cells, leading to pulmonary fibrosis and irreversible damage to lung function. It has been proposed that the connective tissue growth factor (CTGF) plays a critical role in the advancement of pulmonary fibrosis by enhancing the accumulation of the extracellular matrix and exacerbating fibrosis. In this context, the significance of CTGF in pulmonary fibrosis is examined, and a summary of the development of drugs targeting CTGF for the treatment of pulmonary fibrosis is provided. [ABSTRACT FROM AUTHOR]

LINKED CONTENT This article is linked to Ang et al papers. To view these articles, visit https://doi.org/10.1111/apt.17070 and https://doi.org/10.1111/apt.17142 [ABSTRACT FROM AUTHOR]

LINKED CONTENT This article is linked to Ang et al papers. To view these articles, visit https://doi.org/10.1111/apt.17070 and https://doi.org/10.1111/apt.17167 [ABSTRACT FROM AUTHOR]