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1.
Seizure ; 117: 83-89, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38354597

ABSTRACT

BACKGROUND: Generic drug manufacturing has shifted away from the U.S. in the last few decades. The medication supply chain, from manufacturers to resellers, has become increasingly globalized and complex. This has led to bottlenecks in their manufacture resulting in medication shortages. Review of this process as it pertains to antiseizure medications (ASM) shows gaps in our comprehension of its complexities. Understanding these processes will be essential for preventing medication shortages. OBJECTIVES: The aim of this research is to examine the generic ASM supply with an emphasis on production, labeling, and repackaging. METHODS: Data from the United States Food and Drug Administration (FDA) and the National Library of Medicine (NLM) website DailyMed was used to evaluate supply chain details to gather information on antiseizure medication formulations, manufacturing locations, and labeling. RESULTS: Out of 3142 ASM-related active National Drug Code (NDC-9) codes, 2663 NDC-9 codes with Abbreviated New Drug Application (ANDA) status were included in the analysis. Most (94.8 %) were enteral, with only 5.2 % being parenteral (intravenous and intramuscular route). We identified the manufacturing country for 82 % of these codes, corresponding to 306 unique ANDA numbers. 119 manufacturing sites in 12 countries produce generic ASM Finished Dosage Forms (FDF): 103 for enteral and 21 for parenteral. India is the main producer of enteral ASM FDFs with 49 sites, followed by the US with 36. Regarding parenteral formulation, five countries had 21 unique manufacturing locations. 42 % of the 103 enteral ASM FDFs manufacturing sites produced multiple ASM FDFs, with one facility making eight distinct ASMs. 34.4 % of facilities were associated with over 3 ANDAs, and 15.1 % with more than 5. 22.7 % of ANDAs lacked a manufacturing facility identifier. Repackaged ASM FDFs constituted 48 % of NDC-9 s. Gabapentin and pregabalin were the most common oral ASMs. CONCLUSIONS: India is the major source for generic ASM FDFs manufacturing, leading to concerns about overall supply dependency on that country. There is a paucity of facilities for the global supply of parenteral ASM FDFs. There is missing data for many NDC-9 codes emphasizing urgency for transparency in the supply chain.


Subject(s)
Anticonvulsants , Drugs, Generic , Humans , United States , Drugs, Generic/supply & distribution , Anticonvulsants/supply & distribution , Anticonvulsants/therapeutic use , United States Food and Drug Administration , Databases, Factual , National Library of Medicine (U.S.) , Drug Industry
2.
Epilepsy Behav ; 112: 107476, 2020 11.
Article in English | MEDLINE | ID: mdl-33181895

ABSTRACT

The current pandemic of coronavirus disease 2019 (COVID-19) that led to an unprecedented crisis with significant health, social, and economic repercussions presented more serious concerns for those living with some chronic conditions such as epilepsy. This study was aimed to find out impact of the COVID-19 pandemic on management of epilepsy. A cross-sectional study was conducted through telephone interviews, targeting 213 caregivers of pediatric patients with epilepsy, belonging to underserved areas of Faisalabad, Punjab, Pakistan. A simple questionnaire was designed to record the responses of participants relevant to the direct and indirect effects of COVID-19 pandemic and their knowledge about possible ways that can be accessed for the management of epilepsy during an ongoing pandemic. The current study, which holds 77% of the respondents from rural areas and 23% from urban settings, showed that partial measures of lockdown taken to stop or slow the spread of COVID-19 resulted in adverse economic and health outcomes in the said population including cancelation of follow-up visits, worsening of seizures, job loss, burden of antiepileptic drugs (AEDs) costs, and discontinuation of medicines. Furthermore, knowledge about alternative ways to access health facilities was found very poor among caregivers. Income sources of poor people disrupted by lockdown can lead to unintentional nonadherence to medication, which is a clear picture of inequitable distribution of resources. This study highlights the major issues faced by the caregivers during this ongoing pandemic of COVID-19.


Subject(s)
Anticonvulsants , Coronavirus Infections/prevention & control , Coronavirus , Epilepsy/drug therapy , Health Services Accessibility , Pneumonia, Viral/prevention & control , Quarantine/psychology , Social Isolation , Anticonvulsants/economics , Anticonvulsants/supply & distribution , Anticonvulsants/therapeutic use , Betacoronavirus , COVID-19 , Coronavirus Infections/epidemiology , Coronavirus Infections/psychology , Cross-Sectional Studies , Epilepsy/epidemiology , Female , Health Resources , Humans , Longitudinal Studies , Male , Medication Adherence , Pakistan , Pandemics , Pneumonia, Viral/epidemiology , Pneumonia, Viral/psychology , SARS-CoV-2 , Seizures/epidemiology , Surveys and Questionnaires , Telemedicine , Vulnerable Populations
4.
Epilepsy Res ; 167: 106453, 2020 11.
Article in English | MEDLINE | ID: mdl-32927329

ABSTRACT

In the wake of the pandemic COVID-19 and nationwide lockdowns gripping many countries globally, the national healthcare systems are either overwhelmed or preparing to combat this pandemic. Despite all the containment measures in place, experts opine that this novel coronavirus is here to stay as a pandemic or an endemic. Hence, it is apt to be prepared for the confrontation and its aftermath. From protecting the vulnerable individuals to providing quality care for all health conditions and maintaining essential drug supplies, it is going to be a grueling voyage. Preparedness to sustain optimal care for each health condition is a must. With a higher risk for severe COVID-19 disease in infants, need of high-dose hormonal therapy with a concern of consequent severe disease, presence of comorbidities, and a need for frequent investigations and follow-up; children with West syndrome constitute a distinctive group with special concerns. In this viewpoint, we discuss the important issues and concerns related to the management of West syndrome during COVID-19 pandemic in the South Asian context and provide potential solutions to these concerns based on the current evidence, adeptness, and consensus. Some plausible solutions include the continuation of containment and mitigation measures for COVID-19, therapeutic decision- making for West syndrome based on risk stratification, and tele-epileptology.


Subject(s)
Adrenal Cortex Hormones/therapeutic use , Adrenocorticotropic Hormone/therapeutic use , Anticonvulsants/therapeutic use , Coronavirus Infections/drug therapy , Pneumonia, Viral/drug therapy , Spasms, Infantile/drug therapy , Telemedicine , Vigabatrin/therapeutic use , Adrenal Cortex Hormones/supply & distribution , Adrenocorticotropic Hormone/supply & distribution , Anticonvulsants/supply & distribution , Antiviral Agents/administration & dosage , Betacoronavirus , COVID-19 , Clinical Decision-Making , Delivery of Health Care , Drug Interactions , Humans , Infant , Pandemics , SARS-CoV-2 , Time-to-Treatment , Vigabatrin/supply & distribution
5.
Epilepsy Behav ; 112: 107350, 2020 11.
Article in English | MEDLINE | ID: mdl-32920373

ABSTRACT

OBJECTIVE: The objective of this study was to assess access to healthcare and to estimate the prevalence of depression and anxiety among persons with epilepsy (PWE) during the ongoing coronavirus disease 2019 (COVID-19) pandemic. METHODS: We conducted a multicountry online survey among PWE. Persons with epilepsy were invited to participate through various social media channels. The Hospital Anxiety and Depression Scale (HADS) and 9-item Patient Health Questionnaire (PHQ-9) scale were used to score anxiety and depression. Logistic regression modeling was used to investigate factors associated with anxiety and depression. RESULTS: Three hundred ninety-nine PWE were included (mean age: 38.22 ±â€¯12.09 years), the majority were female (80.2%) and living in high-income countries (83.2%). Two hundred three PWE reported symptoms of a cold since January 2020. Nine (25%) of the 36 PWE tested for COVID were positive. A total of 72 PWE (19.6%) reported problems to obtain antiseizure medication (ASM), which in 25% of cases was directly COVID-related. Of the 399 PWE, 201 (50.4%) screened positive for anxiety according to the HADS; 159 (39.8%) and 187 (46.9%) PWE screened positive for depression based on the HADS and PHQ-9 scale, respectively. Female gender and financial problems were associated with both depression and anxiety. A planned follow-up consultation with the treating physician was associated with a lower risk of depression, whereas difficulties to access ASM treatment increased the odds of depression. In 65/137 (47.4%) PWE with a planned follow-up visit with the treating physician, this consultation was canceled. CONCLUSIONS: Innovative approaches are needed to ensure continuity in access to ASM treatment. Healthcare workers should ensure continued follow-up, either through inperson or telehealth appointments, to timely identify symptoms of anxiety and depression and act accordingly.


Subject(s)
Anticonvulsants/therapeutic use , Anxiety/epidemiology , Coronavirus Infections/epidemiology , Depression/epidemiology , Epilepsy/epidemiology , Health Services Accessibility , Pneumonia, Viral/epidemiology , Adult , Anticonvulsants/supply & distribution , Betacoronavirus , COVID-19 , Delivery of Health Care , Epilepsy/drug therapy , Female , Humans , Logistic Models , Male , Middle Aged , Pandemics , Patient Health Questionnaire , Prevalence , Risk Factors , SARS-CoV-2 , Surveys and Questionnaires
6.
Epilepsy Behav ; 112: 107375, 2020 11.
Article in English | MEDLINE | ID: mdl-32858368

ABSTRACT

During epidemic outbreaks, epilepsy course can be modified by different physical and psychological stressors and, most importantly, by irregular therapy intake. The effect of COVID-19 and quarantine isolation on the course of epilepsy and on incidence of new-onset seizures is still unclear. With the aim of managing epilepsy in quarantined patients, three Italian Epilepsy Centers set up telephone consultations using a semistructured interview, allowing a prospective collection of data on seizure course and other seizure-related problems during pandemic. The collected data on seizure course were compared with the analogous period of 2019. The level of patients' concern relating to the COVID-19 pandemic was also assessed using a numeric rating scale. To address the effect of COVID-19 pandemic on seizure incidence, data collection included the number of consultations for first seizures, relapse seizures, and status epilepticus (SE) in the emergency department of one of the participating centers. Clinical telephone interviews suggest the absence of quarantine effect on epilepsy course in our cohort. No differences in incidence of emergency consultations for seizures over a two-month period were also observed compared with a control period. As demonstrated in other infective outbreaks, good antiepileptic drug (AED) supplying, precise information, and reassurance are the most important factors in chronic conditions to minimize psychological and physical stress, and to avoid unplanned treatment interruptions.


Subject(s)
Anticonvulsants/therapeutic use , Coronavirus Infections , Epilepsy/drug therapy , Pandemics , Pneumonia, Viral , Seizures/epidemiology , Telemedicine , Adult , Anticonvulsants/supply & distribution , Betacoronavirus , COVID-19 , Cohort Studies , Female , Humans , Incidence , Italy/epidemiology , Male , Middle Aged , Prevalence , Prospective Studies , Recurrence , Referral and Consultation , SARS-CoV-2 , Seizures/drug therapy , Status Epilepticus/drug therapy , Status Epilepticus/epidemiology
7.
Clin Med (Lond) ; 20(4): e104-e106, 2020 07.
Article in English | MEDLINE | ID: mdl-32518102

ABSTRACT

The COVID-19 pandemic will impact on how care for chronic conditions is delivered. We use epilepsy to exemplify how care for patients will be affected, and suggest ways in which healthcare systems can respond to deliver the most effective care. Where face-to-face outpatient appointments have been cancelled, telemedicine can facilitate remote clinical consultations for new and follow-up epilepsy clinic patients while reducing the risk of infection to both patients and healthcare staff. First-seizure patients will need investigation pathways rationalised, while those with chronic epilepsy will need to have reliable alternative avenues to access clinical advice. At the same time, neurologists should support emergency departments and acute medical units, advising on appropriate management of seizures and other acute neurological presentations. Ultimately, the revolution in our clinical practice is unlikely to cease after this pandemic, with reconfiguration of services likely to bring improvements in efficiency and convenience, and a reduced environmental impact.


Subject(s)
Coronavirus Infections/complications , Epilepsy/complications , Epilepsy/drug therapy , Neurology/organization & administration , Pneumonia, Viral/complications , Telemedicine , Anticonvulsants/supply & distribution , Anticonvulsants/therapeutic use , COVID-19 , Chronic Disease , Emergency Service, Hospital , Epilepsy/diagnosis , Epilepsy/etiology , Humans , Pandemics , Referral and Consultation
8.
Seizure ; 78: 96-101, 2020 May.
Article in English | MEDLINE | ID: mdl-32315955

ABSTRACT

PURPOSE: Three Chapters of the Commission of the East Mediterranean Affairs (CEMA) of the ILAE conducted a survey to assess the availability of drugs used for the treatment of generalized convulsive status epilepticus (GCSE) across the CEMA countries and to evaluate the treatment choices of adult and pediatric neurologists for the treatment of this condition. METHOD: The web-based survey consisted of two similar vignettes of GCSE in a child and an adult. The questions evaluated the sequential drugs of choice based on drug availability and with the assumption that all drugs were at the disposition of the neurologists. The neurologists were also asked about the timing of introduction of anesthetic drugs and how they monitor patients in drug induced coma. RESULTS: Our data showed that the availability of drugs differ substantially across CEMA countries. A benzodiazepine and phenytoin/phenobarbital were the initial drugs of choice for the majority of adults and pediatric neurologists. In cases of refractory status, most neurologists would use a third agent before proceeding to treatment with an anesthetic agent. Although the vast majority would prefer to monitor patients in drug-induced coma with continuous EEG, only 38% are using this modality because of its unavailability at their institutions. CONCLUSIONS: Our data emphasize that an algorithm for the treatment of GCSE in the CEMA countries should be flexible and should propose different treatment options at each step of the protocol that are based on the best available data while taking into consideration the drug availability across the CEMA countries.


Subject(s)
Anticonvulsants/therapeutic use , Drug Resistant Epilepsy/drug therapy , Neurologists/statistics & numerical data , Practice Patterns, Physicians'/statistics & numerical data , Status Epilepticus/drug therapy , Adult , Anticonvulsants/supply & distribution , Child , Clinical Protocols , Health Care Surveys , Humans , Kuwait , Lebanon , United Arab Emirates
9.
Neurocrit Care ; 32(1): 226-237, 2020 02.
Article in English | MEDLINE | ID: mdl-31077080

ABSTRACT

Drug shortages have become all too familiar in the health care environment, with over 200 drugs currently on shortage. In the wake of Hurricane Maria in September 2017, hospitals across the USA had to quickly and creatively adjust medication preparation and administration techniques in light of decreased availability of intravenous (IV) bags used for compounding a vast amount of medications. Amino acid preparations, essential for compounding parenteral nutrition, were also directly impacted by the hurricane. Upon realization of the impending drug shortages, hospitals resorted to alternative methods of drug administration, such as IV push routes, formulary substitutions, or alternative drug therapies in hopes of preserving the small supply of IV bags available and prioritizing them for them most critical needs. In some cases, alternative drug therapies were required, which increased the risk of medication errors due to the use of less-familiar treatment options. Clinical pharmacists rounding with medical teams provided essential, patient-specific drug regimen alternatives to help preserve a dwindling supply while ensuring use in the most critical cases. Drug shortages also frequently occur in the setting of manufacturing delays or discontinuation and drug recalls, with potential to negatively impact patient care. The seriousness of the drug shortage crisis reached public attention by December 2017, when political and pharmacy organizations called for response to the national drug shortage crisis. In this article, we review institutional mitigation strategies in response to drug shortages and discuss downstream effects of these shortages, focusing on medications commonly prescribed in neurocritical care patients.


Subject(s)
Central Nervous System Diseases/therapy , Critical Care , Drug Substitution , Pharmaceutical Preparations/supply & distribution , Pharmaceutical Solutions/supply & distribution , Analgesics, Opioid/supply & distribution , Analgesics, Opioid/therapeutic use , Anticonvulsants/supply & distribution , Anticonvulsants/therapeutic use , Antifibrinolytic Agents/supply & distribution , Antifibrinolytic Agents/therapeutic use , Antihypertensive Agents/supply & distribution , Antihypertensive Agents/therapeutic use , Cooperative Behavior , Drug Compounding , Humans , Intensive Care Units , Pharmacy Service, Hospital , Rehydration Solutions/supply & distribution , Rehydration Solutions/therapeutic use , Solutions/supply & distribution , Solutions/therapeutic use
10.
Epilepsy Behav ; 95: 166-168, 2019 06.
Article in English | MEDLINE | ID: mdl-31063932

ABSTRACT

PURPOSE: On May 8, 2018, the United States announced that it was withdrawing from the Iran nuclear deal. This has resulted in reimposition of the economic hardship on Iran. We investigated the patients' perceptions of hardship in obtaining their antiepileptic drugs (AEDs) after the reimposition of sanctions. METHODS: We surveyed patients with epilepsy visiting three centers in Iran on February 2nd to 6th (easy sampling) on their perceptions on two issues: RESULTS: Two hundred and forty-four patients participated. Ninety-two patients (37.7%) claimed that they have had significant difficulty obtaining their AEDs, and 37 patients (15.2%) said that their AED(s) was not accessible. Ninety-six people (72%) of those receiving imported AEDs and 33 patients (30%) of those receiving homemade AEDs had significant hardship obtaining their drugs (p = 0.00001). Forty-seven patients (36%) of those who reported significant hardship obtaining their AEDs and 25 (22%) of those who did not, perceived worsening of their seizures (p = 0.017). CONCLUSION: Sanctions have affected ordinary people, especially those who are vulnerable the most (i.e., patients), significantly.


Subject(s)
Anticonvulsants/supply & distribution , Epilepsy/drug therapy , Politics , Social Problems , Vulnerable Populations , Adolescent , Adult , Aged , Child , Child, Preschool , Female , Humans , Infant , Iran , Male , Middle Aged , Young Adult
11.
BMC Res Notes ; 11(1): 549, 2018 Aug 02.
Article in English | MEDLINE | ID: mdl-30071884

ABSTRACT

OBJECTIVE: We aimed to provide a reliable evidence-based conclusion around manufacturing, import, availability and sufficiency of one essential medication, phenobarbital (PB) through our example location (Bhutan). The relevant details about manufacturing, import, annual quantity, dose strength were obtained. RESULTS: There was no local manufacturing of PB and all other anti-seizure medications. A total of 1068 vials of PB 200 mg/mL inj and 489,350 tablets of PB30 mg (i.e. 14.6 kilos) was estimated to annually become available. Of this, 5.3 k (36.3%) was present at the basic health units (BHUs). The PB was absent at 26 (14.7%) BHUs. There was no availability of PB syrup. Treating supposed target of 50.0% of the 20.0% of the prevalent case-load (N = 4523) require 18.1 kilo of PB annually. To conclude, having or not the local manufacturing may or may not be a limitation. There is a need to overcome challenges of inappropriate dose strength, absent pediatric formulation, indirect cost, and low selling price of PB. The possible therapeutic participation of PB in managing disease conditions (like epilepsy) remains limited despite favorable safety and efficacy profile. Strengthening the availability of essential medications is essential to reduce the treatment gap and public health burden of treatable disease conditions.


Subject(s)
Anticonvulsants/supply & distribution , Phenobarbital/supply & distribution , Adolescent , Aged , Asia , Bhutan , Child , Child, Preschool , Epilepsy/drug therapy , Female , Humans , Infant , Infant, Newborn , Male , Surveys and Questionnaires
12.
Reprod Health ; 15(Suppl 1): 91, 2018 Jun 22.
Article in English | MEDLINE | ID: mdl-29945665

ABSTRACT

BACKGROUND: Pre-eclampsia and eclampsia are major causes of maternal morbidity and mortality. Magnesium sulphate is accepted as the anticonvulsant of choice in these conditions and is present on the WHO essential medicines list and the Indian National List of Essential Medicines, 2015. Despite this, magnesium sulphate is not widely used in India for pre-eclampsia and eclampsia. In addition to other factors, lack of availability may be a reason for sub-optimal usage. This study was undertaken to assess the availability and use of magnesium sulphate at public and private health care facilities in two districts of North Karnataka, India. METHODS: A facility assessment survey was undertaken as part of the Community Level Interventions for Pre-eclampsia (CLIP) Feasibility Study which was undertaken prior to the CLIP Trials (NCT01911494). This study was undertaken in 12 areas of Belagavi and Bagalkote districts of North Karnataka, India and included a survey of 88 facilities. Data were collected in all facilities by interviewing the health care providers and analysed using Excel. RESULTS: Of the 88 facilities, 28 were public, and 60 were private. In the public facilities, magnesium sulphate was available in six out of 10 Primary Health Centres (60%), in all eight taluka (sub-district) hospitals (100%), five of eight community health centres (63%) and both district hospitals (100%). Fifty-five of 60 private facilities (92%) reported availability of magnesium sulphate. Stock outs were reported in six facilities in the preceding six months - five public and one private. Twenty-five percent weight/volume and 50% weight/volume concentration formulations were available variably across the public and private facilities. Sixty-eight facilities (77%) used the drug for severe pre-eclampsia and 12 facilities (13.6%) did not use the drug even for eclampsia. Varied dosing schedules were reported from facility to facility. CONCLUSIONS: Poor availability of magnesium sulphate was identified in many facilities, and stock outs in some. Individual differences in usage were identified. Ensuring a reliable supply of magnesium sulphate, standard formulations and recommendations of dosage schedules and training may help improve use; and decrease morbidity and mortality due to pre-eclampsia/ eclampsia. TRIAL REGISTRATION: The CLIP trial was registered with ClinicalTrials.gov ( NCT01911494 ).


Subject(s)
Anticonvulsants/supply & distribution , Anticonvulsants/therapeutic use , Eclampsia/drug therapy , Hospitals, Private/organization & administration , Hospitals, Public/organization & administration , Magnesium Sulfate/supply & distribution , Magnesium Sulfate/therapeutic use , Pre-Eclampsia/drug therapy , Primary Health Care/organization & administration , Child , Eclampsia/diagnosis , Female , Health Care Surveys , Health Facilities , Humans , India , Infant, Newborn , Pre-Eclampsia/diagnosis , Pregnancy
13.
Br J Clin Pharmacol ; 84(6): 1354-1363, 2018 06.
Article in English | MEDLINE | ID: mdl-29488252

ABSTRACT

AIMS: The aim of this study was to examine prescribing trends for benzodiazepines and Z-drugs to General Medical Services (GMS) patients in Ireland. METHODS: A repeated cross-sectional analysis of the national pharmacy claims database was conducted for GMS patients aged ≥16 years from 2005 to 2015. Prescribing rates per 1000 eligible GMS population were calculated with 95% confidence intervals (CIs). Negative binomial regression was used to determine longitudinal trends and compare prescribing rates across years, gender and age groups. Duration of supply and rates of concomitant benzodiazepine and Z-drug prescribing were determined. Age (16-44, 45-64, ≥65 years) and gender trends were investigated. RESULTS: Benzodiazepine prescribing rates decreased significantly from 225.92/1000 population (95% CI 224.94-226.89) in 2005 to 166.07/1000 population (95% CI 165.38-166.75) in 2015 (P < 0.0001). Z-drug prescribing rates increased significantly from 95.36/1000 population (95% CI 94.73-96.00) in 2005 to 109.11/1000 population (95% CI 108.56-109.67) in 2015 (P = 0.048). Approximately one-third of individuals dispensed either benzodiazepines or Z-drugs were receiving long-term prescriptions (>90 days). The proportion of those receiving >1 benzodiazepine and/or Z-drug concomitantly increased from 11.9% in 2005 to 15.3% in 2015. Benzodiazepine and Z-drug prescribing rates were highest for older women (≥65 years) throughout the study period. CONCLUSIONS: Benzodiazepine prescribing to the GMS population in Ireland decreased significantly from 2005 to 2015, and was coupled with significant increases in Z-drug prescribing. The study shows that benzodiazepine and Z-drug prescribing is common in this population, with high proportions of individuals receiving long-term prescriptions. Targeted interventions are needed to reduce potentially inappropriate long-term prescribing and use of these medications in Ireland.


Subject(s)
Anti-Anxiety Agents/therapeutic use , Anticonvulsants/therapeutic use , Benzodiazepines/therapeutic use , Hypnotics and Sedatives/therapeutic use , Practice Patterns, Physicians'/trends , Adolescent , Adult , Age Factors , Aged , Anti-Anxiety Agents/supply & distribution , Anticonvulsants/supply & distribution , Benzodiazepines/supply & distribution , Cross-Sectional Studies , Databases, Genetic , Drug Prescriptions , Drug Therapy/trends , Female , Health Care Surveys , Humans , Hypnotics and Sedatives/supply & distribution , Ireland , Male , Middle Aged , Sex Factors , Time Factors , Young Adult
14.
Epilepsia ; 59(2): 468-478, 2018 02.
Article in English | MEDLINE | ID: mdl-29218701

ABSTRACT

OBJECTIVE: Drug shortages are occurring at an increasing rate. From May to October 2016, there was a shortage of a level I critical antiepileptic drug, clobazam. We aimed to study the impact of this shortage on patients with epilepsy. METHODS: Adult patients from Calgary's Comprehensive Epilepsy Program who were taking clobazam were approached to participate in the study. Baseline data from the clinic prospective registry included clinical variables and presurvey patient-reported outcomes (PROs) such as the Global Assessment of Severity of Epilepsy, the Global Assessment of Disability Associated with Seizures, and the Quality of Life in Epilepsy questionnaire. We used a mixed-methods cross-sectional questionnaire via telephone. We analyzed quantitative data using descriptive methods and qualitative data using a phenomenological approach. RESULTS: Of the 85 eligible patients, 84% (n = 71) agreed to participate. Participants ranged from 18 to 78 years old, and 59.2% of participants were female. Overall, 80% of participants experienced some form of medication change due to the shortage. No significant differences were found in the pre- and during-shortage PRO data. However, 6 important themes emerged regarding the impact of the antiepileptic drug shortage on patients: (1) communication and awareness, (2) burden on patients and caregivers, (3) physical impact, (4) psychological impact, (5) health care provider assistance in navigating the shortage, and (6) policy change. SIGNIFICANCE: We examined the impact of the clobazam shortage on patients with epilepsy from the patient's perspective and identified 6 important themes. As a result, we were able to gain insight into what patients need to cope with drug shortages and make recommendations that can help mitigate the impact of shortages on patients in the future. Further research is needed to better understand drug shortages from the patient's perspective in various settings and conditions.


Subject(s)
Anticonvulsants/supply & distribution , Benzodiazepines/supply & distribution , Epilepsy/drug therapy , Quality of Life , Adolescent , Adult , Aged , Alberta , Clobazam , Cohort Studies , Communication , Cost of Illness , Cross-Sectional Studies , Epilepsy/physiopathology , Epilepsy/psychology , Female , Health Policy , Humans , Longitudinal Studies , Male , Middle Aged , Patient Reported Outcome Measures , Qualitative Research , Surveys and Questionnaires , Young Adult
15.
Seizure ; 41: 134-40, 2016 Oct.
Article in English | MEDLINE | ID: mdl-27552381

ABSTRACT

PURPOSE: To determine the accessibility of treatment and the quality of antiepileptic drugs (AEDs) in the Haute Matsiatra district of Madagascar. METHODS: Cross-sectional descriptive study and interviews. Samples of 10 units of each available AED were collected, and the active ingredient was quantified by reversed-phase high-performance liquid chromatography (RP-HPLC) with photodiode-array UV detection. The quality of an AED was considered satisfactory if the quantity of active ingredient in each tablet was in the range ±15% of the average value according to the European Pharmacopeia (6th edition, 2008). RESULTS: The area was well served with health infrastructure but rescue facilities were poorly distributed. Available AEDs were all first-generation, and 73% were generic formulations. People with epilepsy (PWE) surveyed consulted traditional healers and most were treated with plants. PWE did not consider themselves sick but believed they were "possessed"; they consulted a doctor only immediately after a seizure, following the advice of traditional healers. The most prescribed AED was phenobarbital, costing between 0.03 and 0.12 US Dollar (US$) per 100mg. The purchase of full treatment was difficult for 77% of PWE and as a result, 39% took nothing. The quality of AEDs were considered unsatisfactory in 2.8% of cases. CONCLUSION: The AEDs collected in Haute Matsiatra were globally of good quality. The main limiting elements were a lack of knowledge among PWE that epilepsy is a disease, and the cost of traditional treatments.


Subject(s)
Anticonvulsants/supply & distribution , Anticonvulsants/therapeutic use , Epilepsy/drug therapy , Health Services Accessibility , Phenobarbital/supply & distribution , Phenobarbital/therapeutic use , Adolescent , Adult , Anticonvulsants/economics , Cross-Sectional Studies , Epilepsy/economics , Epilepsy/epidemiology , Female , Humans , Madagascar/epidemiology , Male , Phenobarbital/economics , Young Adult
16.
Epilepsia ; 57(4): 671, 2016 Apr.
Article in English | MEDLINE | ID: mdl-27041132
17.
Seizure ; 36: 49-56, 2016 Mar.
Article in English | MEDLINE | ID: mdl-26938970

ABSTRACT

PURPOSE: Most people with epilepsy (PWE) in low-income countries are not treated. We identified risk factors for the epilepsy treatment gap in rural Tanzania. METHODS: We identified adult PWE in a community-based prevalence study. Factors associated with failure to access or default from medical care were identified using logistic regression modelling. RESULTS: A total of 291 PWE were included, of whom 253 (86.9%) had presented to medical services. Failure to present was positively associated with using alcohol (odds ratio (OR) 4.20; 95% confidence interval (CI) 1.63 to 10.82) or attending traditional healers (OR 2.62; CI 1.00 to 6.83) and inversely associated with having completed primary education (OR 0.33; CI 0.11 to 0.96). Default from treatment was associated with being male (OR 3.35; CI 1.39 to 8.09), having a seizure-related injury (OR 2.64; CI 1.12 to 6.19), believing in a supernatural cause for epilepsy (OR 5.44; CI 1.48 to 19.94) or having no expressed knowledge of cause (OR 5.29; CI 1.60 to 17.52). Cases less likely to default had a duration of epilepsy greater than 10 years (OR 0.28; CI 0.09 to 0.90) or had previously received a seizure-related diagnosis (OR 0.25; CI 0.09 to 0.65). Of all 291 PWE included, 118 denied taking AEDs; the epilepsy treatment gap in this population was therefore 40.5% (95% CI 34.9 to 46.2). CONCLUSION: Interventions to improve access to education and to support formal diagnoses may promote access to, and retention under, medical care for PWE in rural Tanzania and in other low-income countries.


Subject(s)
Epilepsy/epidemiology , Epilepsy/therapy , Health Services Accessibility/statistics & numerical data , Rural Population/statistics & numerical data , Adult , Age Distribution , Aged , Aged, 80 and over , Anticonvulsants/supply & distribution , Anticonvulsants/therapeutic use , Female , Humans , Longitudinal Studies , Male , Middle Aged , Regression Analysis , Retrospective Studies , Risk Factors , Tanzania/epidemiology , Young Adult
18.
Brain Dev ; 38(7): 623-7, 2016 Aug.
Article in English | MEDLINE | ID: mdl-26846730

ABSTRACT

BACKGROUND: Takuto Rehabilitation Center for Children is located in Sendai, the capital of the Miyagi prefecture, and faces the Pacific Ocean. The tsunami caused by the Great East Japan Earthquake resulted in tremendous damage to this region. Many physically handicapped patients with epilepsy who are treated at our hospital could not obtain medicine. We surveyed patients with epilepsy, using a questionnaire to identify the problems during the acute phase of the Great East Japan Earthquake. METHODS: After the earthquake, we mailed questionnaires to physically handicapped patients with epilepsy who are treated and prescribed medications at our hospital, or to their parents. RESULTS: A total of 161 respondents completed the questionnaire. Overall, 68.4% of patients had seven days or less of stockpiled medication when the earthquake initially struck, and 28.6% of patients had no medication or almost no medication during the acute phase after the earthquake. Six patients were forced to stop taking their medication and nine patients experienced a worsening of seizures. Most (93.6%) patients stated they require a stockpile of medication for more than seven days: 20months after the earthquake, 76.9% patients a supply of drugs for more than seven days. CONCLUSIONS: We suggest that physically handicapped patients with epilepsy are recommended to prepare for natural disasters by stockpiling additional medication. Even if the stock of antiepileptic drugs is sufficient, stress could cause worsening of seizures. Specialized support is required after a disaster among physically handicapped patients with epilepsy.


Subject(s)
Anticonvulsants/supply & distribution , Disabled Persons , Disasters , Earthquakes , Epilepsy/drug therapy , Epilepsy/physiopathology , Tsunamis , Adolescent , Adult , Anticonvulsants/therapeutic use , Child , Child, Preschool , Disaster Planning , Health Services Needs and Demand , Hospitals, Pediatric , Humans , Intellectual Disability/epidemiology , Japan/epidemiology , Rehabilitation Centers , Seizures/physiopathology , Strategic Stockpile , Time Factors , Young Adult
19.
Epilepsia ; 56(12): e191-7, 2015 Dec.
Article in English | MEDLINE | ID: mdl-26477534

ABSTRACT

Europe consists of 53 countries with widely different economic conditions and different political, educational, and health care systems. This study was aimed at determining the availability of antiepileptic drugs (AEDs) across Europe. An electronic questionnaire was submitted to all 43 European chapters of the International League Against Epilepsy (ILAE). Outcome measures were availability of older, newer, and newest AEDs, generic products, indications, reimbursement rules, and reasons for lack of availability of AEDs. Countries were divided according to economic status as defined by the World Bank. Thirty-four chapters (79%) provided data. There were large differences in AED availability across countries, especially between high-income countries and the other countries. The newest AEDs were not available in any of the 12 non-high-income countries. Availability was higher in countries with public reimbursement systems. Reimbursement policies ranged from full reimbursement for all AEDs to complete lack of reimbursement. Main hurdles for poor access to AEDs included lack of regulatory approval, high prices and reimbursement restrictions. The availability of AEDs differs across European countries, with many hurdles hampering access to epilepsy medicines, particularly to new medications. These findings raise major concerns on the quality of epilepsy care in many countries.


Subject(s)
Anticonvulsants/supply & distribution , Epilepsy/drug therapy , Europe , Humans , Insurance, Health, Reimbursement , Reimbursement Mechanisms , Surveys and Questionnaires
20.
Epilepsy Behav ; 51: 267-72, 2015 Oct.
Article in English | MEDLINE | ID: mdl-26312988

ABSTRACT

Very little has been reported about the health resources available for patients with epilepsy in the five English-speaking southern Caribbean countries of Trinidad and Tobago, Barbados, Grenada, Saint Vincent and the Grenadines, and Saint Lucia. There is no comprehensive resource describing their health systems, access to specialty care, antiepileptic drug (AED) use, and availability of brain imaging and EEG. The purpose of this study was to profile epilepsy care in these countries as an initial step toward improving the standard of care and identifying gaps in care to guide future policy changes. In each southern Caribbean country, we conducted study visits and interviewed health-care providers, government health ministers, pharmacy directors, hospital medical directors, pharmacists, clinic staff, radiologists, and radiology and EEG technicians. Health-care providers completed extensive epilepsy care surveys. The five countries all have integrated government health systems with clinics and hospitals that provide free or heavily subsidized care and AEDs for patients with epilepsy. Only Trinidad and Tobago and Barbados, however, have neurology specialists. The three smaller countries lack government imaging and EEG facilities. Trinidad had up to one-year waits for public MRI/EEG. Government formularies in Grenada, Saint Vincent and the Grenadines, and Saint Lucia are limited to first-generation AEDs. One or more second-line agents are formulary in Trinidad and Barbados. Nonformulary drugs may be obtained for individual patients in Barbados. Grenada, Saint Lucia, and Saint Vincent and the Grenadines participate in an Organization of Eastern Caribbean States formulary purchasing system, which added levetiracetam following the survey. Newer generic AED formulations with the lowest risks for pregnancy malformation were not in use. In conclusion, patients with epilepsy in the southern Caribbean have excellent access to government clinics and hospitals, but AED choices are limited. Local medical providers reported that the major limitations in care were lack of specialty care, lack of imaging and EEG services, financial barriers to care, long wait times for care, and limited access to additional AEDs.


Subject(s)
Delivery of Health Care/statistics & numerical data , Epilepsy/epidemiology , Epilepsy/therapy , Anticonvulsants/supply & distribution , Barbados , Caribbean Region/epidemiology , Developing Countries , Drug Utilization , Electroencephalography , Female , Formularies as Topic , Health Personnel/statistics & numerical data , Health Services Accessibility/statistics & numerical data , Humans , Male , Neurology/statistics & numerical data , Pregnancy , Saint Lucia , Saint Vincent and the Grenadines
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