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OBJECTIVES/GOALS: To facilitate the development of innovative injection products by providing translational researchers with a regulatory and manufacturing road map for producing small batch sterile products for Phase 1 research use. To leverage recent AMC investments in facility improvements and pharmacy training in the areas of sterile product production, testing, and environmental controls, that can be used to support production of phase 1 clinical trial supplies METHODS/STUDY POPULATION: Searching and organizing relevant data and information from web portals and databases in the following: areas: FDA, EMA, USP regulations, regulatory science, pharmaceutical formulation and analytics, supply vendors, analytical testing laboratories, and product testing laboratories. Present the information using a user friendly format including flow charts and development timelines, taking the perspective of the translational investigator. RESULTS/ANTICIPATED RESULTS:
Choosing AMC resources vs outside consultants and vendors, leveraging local resources where possible
Qualifying and monitoring suppliers, testing laboratories, in-house departments, and Contract Drug Manufacturing Organizations (CDMO)
Bringing together the deliverables for the IND CMC section
Where and how to leverage available products and science to simplify safe and reliable production
DISCUSSION/SIGNIFICANCE OF IMPACT: Use and utility of injectable drug products, both small molecule and biologics, is growing rapidly, and is projected to continue to escalate well into the next decade. This is due not only to advances in medicine, but also to improvements in AMC-based sterile product production, and a better understanding of small batch manufacturing methods. All three trends align in academic medical centers (AMC) and can be utilized by translational researchers, if they can understand the potential and regulatory requirements.
OBJECTIVES/GOALS: 1. Understand the association between patient perceptions of care measured by the Interpersonal Processes of Care (IPC) Survey and glycemic control, appointment no-shows/cancellations and medication adherence in patients with type II diabetes. 2. Determine how these relationships differ by race for non-Hispanic White and Black patients. METHODS/STUDY POPULATION: This is a cross-sectional study of a random sample of 100 White and 100 Black Type II diabetic patients followed in Duke primary care clinics and prescribed antihyperglycemic medication. We will recruit through email and phone calls. Enrolled patients will complete the Interpersonal Processes of Care Short Form and Extent of Medication Adherence survey to measure patient perceptions of care (predictor) and medication adherence (secondary outcome). No show appointments and cancellations (secondary outcomes) and most recent hemoglobin A1c (primary outcome) will be collected from the Electronic Medical Record. We will also collect basic demographic information, insurance status, financial security, significant co-morbidities, and number and type (subcutaneous vs oral) of antihyperglycemic medications. RESULTS/ANTICIPATED RESULTS: -The study is powered to detect a 0.6% difference in HbA1c, our primary outcome, between high and low scorers on the Interpersonal Processes of Care subdomains. -We expect that higher patient scores in the positive domains of the IPC survey and lower DISCUSSION/SIGNIFICANCE OF IMPACT: This study will provide information to develop and implement targeted interventions to reduce racial and ethnic disparities in patients with Type II diabetes. We hope to gain information on potentially modifiable factors in patient-provider interactions that can be intervened upon to improve prevention and long-term outcomes in these populations.
This presentation will describe a prospective study, due to commence in March 2010, to evaluate the use of Protected Engagement Time in adult acute inpatient wards in three mental health trusts in England.
Patients on acute psychiatric wards in the UK have recurrently reported that they are unhappy with the ward environment, that they are bored and have little to do, that wards are intimidating, and above all, that contact between staff and patients is often identified as too limited in both quantity and quality, and as lacking therapeutic content.
Protected Engagement Time (PET) has emerged as a promising initiative for improving quantity and usefulness of staff-patient contact. During fixed periods of the day, staff are asked to focus solely on patient contact, and are relieved of their administrative duties. However, we do not have any evidence about whether it works or how it should be implemented to achieve the best results.
This study aims to address this lack of evidence and will have three components:
a) A national survey investigating how widespread PET now is in England
b) Evaluation of the effects of PET on patients and staff by comparing 12 wards with PET and 12 wards without, by investigating staff-patient interactions, patient satisfaction, staff burnout and perceptions of the ward environment.
c) In-depth qualitative case studies on three wards with PET.
The objectives for each component and the measures used will be described in detail in the presentation, in addition to an update of study progress.
Whilst steady progress has been made in the development and dissemination of valid and reliable instruments for evaluation of patient outcomes, progress in establishing standard methodologies for description and classification of mental health services has been limited. Valid and reliable methods of describing and classifying services are needed in mental health services research for purposes including; i) comparison of levels of provision between catchment areas and countries; ii) reaching an understanding of the relationship between socio-demographic indicators and service use; iii) investigation of the degree to which one service may be substituted for another; iv) evaluating programme implementation; and v) understanding why different outcomes are observed from apparently similar treatment programmes. Where programmes of research encompass different countries, the need for methods of comparing the local service contexts is particularly acute. In this paper, the various contributions which have been made to the somewhat fragmented body of research in this area are reviewed, and the problems which have hampered the development of satisfactory instruments are discussed. A set of criteria for satisfactory service measurement methodologies is proposed: these include development of standard nomenclature and operational definitions of service types; clear demonstration of validity and reliability; comprehensiveness; and applicability and similar interpretation in a range of countries.
To examine the efficacy and tolerability of quetiapine SR in patients with schizophrenia switched from quetiapine IR.
Randomised, double-blind study (D1444C00146) using dual-matched placebo. Patients clinically stable on fixed doses of quetiapine IR received twice-daily quetiapine IR 400, 600 or 800 mg/day for 4 weeks. Stable patients were then randomised (1:2) to continue taking quetiapine IR or switch to the same total dose of quetiapine SR (active dose once-daily in the evening) for 6 weeks. Primary analysis: % of patients (modified ITT population) discontinuing due to lack of efficacy or with PANSS total increase ≥20% at any visit, using a 6% non-inferiority margin for the upper 95% CI of the treatment difference. Per-protocol (PP) analysis was also performed.
497 patients were randomised (quetiapine SR 331, IR 166); completion rates were 91.5% and 94.0%, respectively. Few patients discontinued due to lack of efficacy or had a PANSS increase ≥20% in both the MITT (n=496) and PP populations (n=393): 9.1% and 5.3% for quetiapine SR and 7.2% and 6.2% for quetiapine IR, respectively. Quetiapine SR was non-inferior to quetiapine IR in the PP population (treatment difference: -0.83% [95% CI -6.75, 3.71]; p=0017) but not in the MITT population (treatment difference: 1.86% [95% CI -3.78, 6.57]; p=0.0431). The incidence (quetiapine SR 38.7%; IR 35.5%) and profile of AEs were similar in both groups.
Clinically-stable patients receiving quetiapine IR can be switched, without titration, to an equivalent once-daily dose of quetiapine SR without any clinical deterioration or compromise in tolerability.
Optimal management of schizophrenia in adolescents is limited by the lack of available therapies. The efficacy and tolerability of aripiprazole was investigated in this patient population.
This 6-week, randomized, double-blind, placebo controlled trial was conducted at 101 international centers, with a safety monitoring board. 13-17 year-olds with a DSM-IV diagnosis of schizophrenia were randomized to placebo, or a fixed dose of aripiprazole 10 mg or 30 mg reached after a 5 or 11 day titration, respectively. The primary endpoint was mean change from baseline on the PANSS Total score at week 6. Secondary endpoints included the PANSS Positive and Negative subscales, and CGI Improvement score. Tolerabilility assessements included frequency and severity of adverse events, as well as blood chemistries, metabolic parameters and weight gain.
Over 85% of 302 patients completed this study. Both 10 mg and 30 mg doses were superior to placebo on the primary endpoint (PANSS total), with significant differences observed as early as Week 1 (30mg). Both doses showed significant improvement on the PANSS Positive and CGI-I scales; and the 10 mg dose group was superior on PANSS Negative score. Approximately 5% of aripiprazole patients discontinued due to AEs. Weight gain and changes in prolactin were minimal.
10mg and 30mg doses of aripiprazole were superior to placebo in the treatment of adolescents with schizophrenia. Aripiprazole was well tolerated, in general, with few discontinuations due to AEs. EPS was the most common AE. Change in body weight was similar to placebo.
Improving the quality of care on psychiatric inpatient wards has been a major focus in recent mental health policy, a recurrent criticism being that contact between staff and patients is limited in time and therapeutic value. Change is unlikely to be achieved without recruitment and retention of a high quality and well-motivated work force.
The NHS commissioned national inpatient mental health staff morale study is intended to inform service planning and policy by delivering evidence on the morale of the inpatient mental health workforce and the clinical, organisational, architectural and human resources factors that influence it.
100 wards in 17 area ‘Trusts’ are participating in the study, in addition to 40 community teams. The study will take place over two years, and has 6 modules:
1. A quantitative questionnaire for all staff in participating wards and
2. A comparison group in 20 community mental health teams and 20 crisis teams.
3. Case studies of 10 wards scoring in the top and bottom quartile for indicators of morale.
4. Repeated questionnaires for 20 wards in the second year to investigate how morale changes over time.
5. Staff who leave the wards in the course of the first year will be asked their reasons for leaving.
6. Links between rates of staff sickness and morale will be investigated.
Questionnaires have been distributed to 3,500 staff with a response rate of 65%, results from which will be presented in 2009.
Revolving Door Syndrome usually corresponds to what might be called “hospital multiple readmissions phenomenon”. Beyond consequences to the patients and their families, frequent re-readmissions also heavily increase healthcare cost and cause burn out among medical and paramedical staff.
The objective of this study was to find the characteristics of Tunisian patients with “revolving door” syndrome.
The purpose of this study was to identify factors associated to short-term readmissions in a sample of Tunisian patients with schizophrenia.
The authors conducted a retrospective study on 50 patients with schizophrenia or schizo-affective disorders from November to february 2009 in Razi Hospital's “Psychiatry C” service. Patients included in the study had been hospitalized at least 4 times. The patients were analyzed for socio-demographic characteristics, total readmissions and the number of admissions in the last year. Their medication adherence was evaluated by MARS (Medication Adherence Rating Scale) and their insight was evaluated by the Q8 scale.
The sample was composed of 50 patients with schizophrenia or schizo-affective disorders according to DSM-IV, more than 18 years of age, which have been hospitalized more than 4 times.
The sample was composed of 80% men. 74% of the sample was single and 66% were living with their parents. 88% were unemployed. 54% of patients were bad observers and 88% had lack of insight.
The authors found that the typical Tunisian revolving door patient is a single man, living at his parent's, unemployed and with a lack of observation skills and insight.
Lithium is a drug which may cause thyroid dysfunction. The most widely known dysfunctions associated with long-term lithium treatment are goiter and hypothyroidism.
Lithium associated thyrotoxicosis is however uncommon.
This current review explores the common mechanisms of lithium induced hyperthyroidism.
A systematic review of database was made using PubMed. The search keywords used were lithium therapy, thyroid side effects, thyroid dysfunction mechanism, hyperthyroidism, thyrotoxicosis.
Lithium induced hyperthyroidism is uncommon, the incidence rate varying from 0.1% to 1.7%.
The mechanisms of lithium associated hyperthyroidism are uncertain.
Recent studies have proved that high proportion of investigated patients experienced transient thyrotoxicosis and painless thyroiditis.
Different mechanisms have been discussed, including autoimmune inflammation, direct cellular destruction, susceptible individuals with preexisting Grave’s disease, a rebound effect of lithium therapy interruption…
The pathogenesis of painless thyroiditis is unclear but different studies suggest a possible direct toxic effect of lithium on the thyroid gland.
Lithium stimulates thyroid autoimmunity: lithium treated patients presented more positive antithyroid peroxidase antibodies than not lithium treated patients. This could be explained by an increased activity of B-cell lymphocyte activity and reduced ratios of suppressor to cytotoxic T-cell lymphocyte.
Long term lithium treated patients should be monitored for the development of thyroid dysfunction. It’s recommended to perform thyroid function test, thyroid antibodies and thyroid ultrasonography with a closer follow-up for lithium-treated patients with thyroid antibodies, or family history of thyroid disease.
Adequate pathways to care are a prerequisite for early detection and intervention in First Episode Psychosis (FEP). Two systematic reviews examined the influence of ethnicity, social and clinical factors on psychosis care pathways. Accessibility to health services differs for under 18s, yet differences in care pathways between age groups and the impact of family factors have not been investigated.
To investigate the influence of family factors in help-seeking pathways for adolescents with FEP.
Naturalistic crossectional study of 1351 FEP (14-35 years) referred to Early Intervention Psychosis teams (London, UK; 2003-2009). Care pathways included accounts on who initiated help-seeking process, initial contact points (GP, emergency services, education, social services, police and court/prison), and family factors (social support, living arrangements and family load of mental illness).
For the majority of adolescents (n=118) and adults (n=1232), first and second contact points were GP (30% vs 42%) and emergency services (18% vs 23%). However, these two services accounted for less than half of the adolescents’ sample. Adolescents made higher use of education (p<0.001). Family factors, such as good social support (p=0.036), living with carers (p<0.001) and family load of mental illness (p=0.018), were associated with family taking a leading role in problem recognition.
Adolescents with psychosis differ from adults in their contact points when seeking help. Problem recognition is a complex process which involves identifying and legitimizing mental health concerns. Parental awareness and perception of problems revealed as a key step in seeking help for adolescents.
Cannabis use has demonstrated an association with earlier onset of psychosis. Investigation of sociodemographic and clinical characteristics in association with cannabis use in adults with first-episode psychosis (FEP) has resulted in inconsistent findings. The clinical profile of cannabis users amongst adolescents with FEP remain widely understudied.
To investigate the frequency of cannabis use, and its association with sociodemographic and clinical characteristics in adolescent-versus adult-onset FEP.
Naturalistic cross-sectional study of 1363 FEP cases aged 14-35 (136 with adolescent-onset psychosis) referred to Early Intervention Services for psychosis in London (UK) (2003-2009). Sociodemographic and clinical data (age of psychosis onset, symptom domains, substance misuse, insight, violence, global functioning, and duration of untreated psychosis [DUP]) were collected at entry to EIS.
Cannabis users were more likely to be male (78.2%), White (43.0%) and unemployed (72.0%). No significant difference was found in cannabis abuse/dependence frequencies between adolescents (28.4%) and adults (24.7%). Cannabis abuse/dependence was associated with an earlier onset of psychosis by 2 years (p<0.001), greater manic and positive symptoms (p<0.001), increased violence (p=0.011), and poorer functioning (p=0.013) and insight (p=0.003). For adolescents, cannabis abuse/dependence was associated with greater positive symptoms, poorer functioning and longer DUP.
Cannabis use shapes the clinical presentation of FEP individuals. Similar frequencies of cannabis use between age groups suggest that substance misuse services should be provided to all, aiming to reducing consumption. Greater vigilance amongst clinicians would enable earlier detection of psychosis in substance misusing adolescents, to reduce DUP and minimise associated poor outcomes.
The prodromal phase of schizophrenia is the time interval preceding a first psychotic episode. It begins with the appearance of nonspecific symptoms. It ends with the outbreak of an episode meeting the diagnostic criteria for schizophrenia. This phase is considered a key period in the prognosis of the disease because it provides access to early diagnosis.
Identify the symptoms of the prodromal phase of schizophrenia and point out the duration of their development in a sample of Tunisian patients.
Detect the specifities of prodromal phase in Tunisia.
15 schizophrenia patients with illness duration of less than 3 years were included. All patients were in clinical remission from at least 3 months (PANNS and BPRS). Exclusion criteria were any history of other psychiatric or neurological disorders and alcohol or drug abuse. Prodromal symptoms were assessed with the scale of prodromal symptoms (SOPS) developed by Mc Glashan. It is a heteroquestionnaire for patients and their parents.
The mean duration of prodromal phase was about 2 years with extremes ranging from 6 months to 4 years.
The most severe prodromal symptoms were suspiciousness/ persecutory ideas, social isolation, dysphoric mood and impaired tolerance to normal stress
The most frequent prodromal symptoms were impaired tolerance to normal stress, dysphoric mood, sleep disturbance, social isolation and suspiciousness/ persecutory ideas.
We have not found any difference between male and female.
The prodromal symptoms of schizophrenia found in the Tunisian socio cultural context are similar to those found in other countries.
GXR, a selective α2A-adrenergic agonist, is a non-stimulant treatment for ADHD (approved in the USA for children and adolescents and in Canada for children).
To assess the efficacy (symptoms and function) and safety of dose-optimized GXR compared with placebo in children and adolescents with ADHD.
To evaluate the efficacy (symptom and function) and safety of GXR for the treatment of ADHD. An atomoxetine (ATX) arm was included to provide reference data against placebo (NCT01244490).
Patients (6–17 years) were randomly assigned at baseline to dose-optimized GXR (6–12 years, 1–4 mg/day; 13–17 years, 1–7 mg/day), ATX (10–100mg/day) or placebo for 4 or 7 weeks. The primary efficacy measure is change from baseline in ADHD-Rating Scale-version IV (ADHD-RS-IV). Key secondary measures were defined as Clinical Global Impressions-Improvement (CGI-I) and the Weiss Functional Impairment Rating Scale-Parent (WFIRS-P). Safety assessments included treatment-emergent adverse events (TEAEs), electrocardiograms, and vital signs.
Of 338 patients randomized, 272 (80.5%) completed the study. Placebo-adjusted differences in least squares (LS) mean in ADHD-RS-IV total score, percent improvement versus placebo for CGI-I, placebo-adjusted differences in LS mean change from baseline in WFIRS-P score (family and learning and school domains) are shown in the Table. The most common TEAEs for GXR were somnolence, headache, and fatigue; 8 (7%) TEAEs were severe.
GXR was effective and well tolerated in children and adolescents with ADHD.
Placebo-adjusted difference in LS mean change from baseline in ADHD-RS-IV total score (95% Cl, p-value; effect size)
−8.9 (−11.9, −5.8, p<0.001; 0.76)
−3.8 (−6.8, −0.7, p<0.05; 0.32)
Difference in improvement from placebo for CGI-I (95% Cl, p-value)
23.7% (11.1, 36.4; p<0.001)
12.1% (−0.9, 25.1; p<0.05)
Placebo-adjusted difference in LS mean change from baseline in WFIRS-P; learning and school domain score (95%CI, p-value; effect size)
−0.22 (−0.36, −0.08, p<0.01; 0.42)
−0.16 (−0.31, −0.02, p<0.05; 0.32)
Placebo-adjusted difference in LS mean change from baseline in WFIRS-P; family domain score (95%CI, p-value; effect size)
Research has suggested that schizophrenia involves significant deficits in executive functioning. Yet, the literature has little studied patients with a recent onset of first episode of schizophrenia. Besides, only few studies have focused on symptom-free intervals. Furthermore, previous studies have included patients under polymedication of antipsychotics without any restriction on other psychotropes.
To investigate executive functions in remitted patients with recent onset of first episode of schizophrenia receiving only a monotherapy of antipsychotics.
Executive dysfunction in schizophrenia is not a consequence of the long term course of the disease, of the relapses, of the symptoms or of the polymedication.
25 schizophrenic outpatients with less than 3 years of illness duration and only one psychotic episode were included. All patients received a monotherapy of antipsychotics and none had an antidepressant, mood stabilizer, hypnotics or benzodiazepines. 25 healthy participants were matched according to age and educational level.
Patients were assessed by the Positive and Negative Syndrome Scale. Executive functions were assessed by the Davidson et al. computerized battery designed to manipulate inhibition and cognitive flexibility vary demands on these abilities.
Compared to healthy controls, remitted schizophrenia patients have shown significant differences in the percentage of correct responses and in the reaction time. This indicates a disorder in inhibition and in cognitive flexibility.
Our results reinforce the findings that the executive dysfunction in schizophrenia stands for itself and that it cannot be explained by relapses, duration of the disease and impact of medication or symptoms.
Schizophrenia is a serious mental illness that carries a significant burden for families providing care.
The ADHES carers' survey canvassed opinions of families/friends of patients with schizophrenia across Europe.
To ascertain carer attitudes towards schizophrenia, its treatment and treatment adherence.
The survey was conducted from January-April 2011 in 16 European countries, comprising 10 questions relating to the respondents' understanding of schizophrenia, attitudes towards schizophrenia treatments, and perception of the family's/friend's role in supporting patients with schizophrenia.
Results were obtained from 138 respondents. 76% of carers recognized the importance of medication to help patients get better, improve their quality of life (77%) and relationships (74%). 67% of carers responded that they believed schizophrenia treatment damages patients' general health. Two-thirds of the carers reported that treatment adherence was a burden for the patient and over a third of carers indicated that it was a daily struggle to get patients to take their medication. 50% of carers considered the benefits offered by long-acting injectable antipsychotics as very/quite important and thus, could provide a valuable tool in improving treatment adherence. 92% of carers agreed on the importance of family support to boost treatment adherence with education/information deemed important for families and patients alike.
Carers recognize the issues they face in caring for patients with schizophrenia and their role in improving partial/non-adherence to medication, especially to avoid suboptimal treatment outcomes. The important role of family carers should be considered by healthcare professionals when treating patients with schizophrenia.
GXR, a selective α2A-adrenergic agonist, is a non-stimulant ADHD treatment approved in the USA for children and adolescents, and in Canada for children.
To evaluate long-term maintenance of efficacy of GXR in children and adolescents with ADHD who respond to an initial open-label, short-term trial.
To determine if there is a higher rate of treatment failure for placebo vs GXR during the double-blind randomised-withdrawal phase (RWP) (NCT01081145).
Patients (6–17 years) meeting DSM-IV-TR criteria for ADHD, baseline ADHD Rating Scale-IV (ADHD-RS-IV) ≥32 and Clinical Global Impressions-Severity (CGI-S) ratings ≥4 were enrolled. Following 7-week dose optimization and 6-week maintenance periods on open-label GXR (1–7 mg/day), eligible patients entered a 26-week, double-blind, RWP with GXR or placebo. The primary endpoint was rate of treatment failure (≥50% increase in ADHD-RS-IV total score and ≥2-point increase in CGI-S at two consecutive visits, compared to the RWP baseline). The key secondary endpoint was time-to-treatment failure. Safety assessments included treatment-emergent adverse events (TEAEs), electrocardiograms and vital signs.
Of 528 patients enrolled, 316 (60.0%) entered the RWP. At study end, 49.3% (GXR) and 64.9% (placebo) (95%CI; −26.6, −4.5, p<0.01) of patients had relapsed (Figure). Time-to-treatment failure was 56 days (placebo) versus 218 days (GXR), p=0.003. During the RWP, the most common GXR TEAEs (≥5% patients) were headache, somnolence and nasopharyngitis.
GXR demonstrated long-term maintenance of efficacy versus placebo in children and adolescents with ADHD.
Fossil fishes are among the rarest in volcanic oceanic islands, their presence providing invaluable data for the understanding of more general (palaeo)biogeographical patterns and processes. Santa Maria Island (Azores Archipelago) is renowned for its palaeontological heritage, with representatives of several phyla, including the Chordata. We report on the fossil fishes, resulting in an increase in the number of Pliocene fishes from the Azores to 11 taxa: seven Chondrichthyes and at least four Actinopterygii. The genus Sparisoma is reported for the first time in the fossil record. The presence of fossil remains of the parrotfish Sparisoma cretense in Last Interglacial outcrops is significant, because it posits a setback for the theory that most of the present-day Azorean marine species colonized the area after the last glacial episode. Our multidisciplinary approach combines palaeontological data with ecological and published genetic data, offering an alternative interpretation. We suggest that most of the Azorean shallow-water subtropical and temperate marine species living in the archipelago during the Last Interglacial were not affected by the decrease in sea surface temperatures during the last glacial episode. We also predict low genetic diversity for fish species presently living in the Azores and ecologically associated with fine sediments, as a result of the remobilization and sediment transport to abyssal depths, during the Last Glacial episode; these are viewed as post-glacial colonizers or as ‘bottleneck’ survivors from the Last Glaciation.
This retrospective study highlights the degree of losses and time-course through which the 2015 highly pathogenic avian influenza (HPAI) outbreaks in Ghana were managed. A total of 102 760 birds from 35 farms across five regions in Ghana included in this study were affected. Out of this, 89.3% was from the Greater Accra region. Majority of the birds were culled (94.2%). Adult layers were most affected and destroyed (64.0%), followed by broilers (13.7%). Event initiation to reporting averaged 7.7 ± 1.3 days (range: 1–30 days). Laboratory confirmation to depopulation of birds averaged 2.2 ± 0.5 (0–15) days while depopulation to disinfection took 2.2 ± 0.7 (0–20) days. Overall, some farms took as long as 30 days to report the outbreak to the authorities, 15 days from confirmation to depopulation and 20 days from depopulation to disinfection. On average, outbreak management lasted 12.3 (2–43) days from event initiation to depopulation. The study reveals a significant number of avian losses and delays in HPAI reporting and management by the authorities in Ghana during the 2015 outbreak. This poses a high risk of spread to other farms and a threat to public health. Awareness creation for poultry farmers is necessary for early reporting, while further study is required to set thresholds for the management of such outbreaks by veterinary departments.