Pharmacokinetics of a 503B outsourcing facility-produced theophylline in dogs.

Theophylline is an important drug for treatment of canine chronic bronchitis and bradyarrhythmias, but new products require validation since pharmacokinetics in dogs can vary by formulation. A new, 503B outsourcing facility-produced theophylline product (OFT) is available for veterinary use. Outsourcing facilities have many advantages over traditional compounding sources including current good manufacturing practice compliance. The purpose of this study was to establish the pharmacokinetics of OFT in dogs. Eight healthy dogs received 11 mg/kg intravenous aminophylline and 10 mg/kg oral OFT followed by serial blood sampling in a two-way, randomized, crossover design with 7-day washout. Plasma theophylline concentrations were quantified by liquid chromatography-mass spectrometry. Bioavailability, maximum concentration, time to maximum concentration, half-life and area under the curve were: 97 ± 10%, 7.13 ± 0.71 µg/mL, 10.50 ± 2.07 h, 9.20 ± 2.87 h, and 141 ± 37.6 µg*h/mL, respectively. Steady-state predictions supported twice daily dosing of the OFT, but specific dosage recommendations are hindered by lack of a canine-specific therapeutic range for plasma theophylline concentration. These findings suggest that the OFT is well absorbed and can likely be dosed twice daily in dogs, but future pharmacodynamic and clinical studies are needed to establish a definitive therapeutic range for theophylline in this species.

The High Stakes of Outsourcing in Health Care.

Outsourcing in health care has become increasingly common as health system administrators seek to enhance profitability and efficiency while maintaining clinical excellence. When clinical services are outsourced, however, the outsourcing organization relinquishes control over its most important service value: high-quality patient care. Farming out work to an external service provider can have many unintended results, including inconsistencies in standards of care; harmful medical errors; declines in patient and employee satisfaction; and damage to clinicians' morale and income, and to the health organization's culture, reputation, and long-term financial performance. Research on outsourcing in the areas of emergency medicine, radiology, laboratory services, and environmental services provides concerning evidence of potentially large downsides when outsourcing is driven by short-term cost concerns or is planned without diligently considering all of the ramifications of not keeping key clinical and nonclinical services in-house. To better equip health system leaders for decision-making about outsourcing, we examine this body of literature, identify common pitfalls of outsourcing in specific clinical and nonclinical health services and scenarios, explore alternatives to outsourcing, and consider how outsourcing (when necessary) can be done in a strategic manner that does not compromise the values of the organization and its commitment to patients.

"Tricks and tips for home mechanical ventilation" Home mechanical ventilation: set-up and monitoring protocols.

In this part of the review series "Tricks and tips for home mechanical ventilation", we will discuss the evidence with regard to the place and manner of home mechanical ventilation initiation and follow-up. Outsourcing more and more of this chronic care to the home situation is a big challenge for the future: especially for the home situation, monitoring has to be non-invasive, reliable and easy to use, data security needs to be ensured, signals need to be integrated and preferably automatically processed and algorithms need to be developed based on clinically relevant outcomes.

Does Community Outsourcing Improve Timeliness of Care for Veterans With Obstructive Sleep Apnea?

BACKGROUND: Providing timely access to care has been a long-standing priority for the Veterans Affairs Healthcare System. Recent strategies to reduce long wait times have focused on purchasing community care by a fee-for-service model. Whether outsourcing Veterans Affairs (VA) specialty care to the community improves access is unclear. OBJECTIVES: We compared time from referral to treatment among Veterans whose care was provided by VA versus community care purchased by the VA, using obstructive sleep apnea as an example condition. METHODS: This was a retrospective cohort study of Northern California Veterans seeking sleep apnea care through the San Francisco VA Healthcare System between 2012 and 2018. We used multivariable linear regression with propensity score matching to investigate the relationship between time to care delivery and care setting (VA provided vs. VA-purchased community care). A total of 1347 Northern California Veterans who completed sleep apnea testing within the VA and 88 Veterans who completed sleep apnea testing in the community had complete data for analysis. RESULTS: Among Northern California Veterans with obstructive sleep apnea, outsourcing of care to the community was associated with longer time from referral to therapy (mean±SD, 129.6±82.8 d with VA care vs. 252.0±158.8 d with community care, P<0.001) and greater loss to follow-up. CONCLUSIONS: These findings suggest that purchasing community care may lead to care fragmentation and not improve wait times nor improve access to subspecialty care for Veterans.

Encuesta de situación de la telefarmacia aplicada a la atención farmacéutica a pacientes externos de los servicios de farmacia hospitalaria en España durante la pandemia por la COVID-19 / Survey on the situation of telepharmacy as applied to the outpatient care in hospital pharmacy departments in Spain during the COVID-19 pandemic

OBJETIVO: Analizar la situación de la implantación y desarrollo de la telefarmacia aplicada a la atención farmacéutica a pacientes externos de los servicios de farmacia hospitalaria en España durante la pandemia por la COVID-19. MÉTODO: Se envió una encuesta online de 10 preguntas a todos los socios de la Sociedad Española de Farmacia Hospitalaria a las seis semanas del inicio del periodo de confinamiento por la pandemia. Se solicitó una única respuesta por hospital. Se incluyeron preguntas sobre la realización de atención farmacéutica no presencial con dispensación a distancia previa al inicio de la crisis sanitaria, los criterios de selección de pacientes, los procedimientos de envío de medicación y los medios utilizados, el número de pacientes que se han beneficiado de la telefarmacia y el número de envíos realizados. Por último, se identificó la realización o no de teleconsulta previa al envío de medicación y si la actividad quedó registrada. RESULTADOS: Un 39,3% (n = 185) del total de hospitales públicos del Sistema Nacional de Salud pertenecientes a todas las comunidades autónomas respondieron a la encuesta. El 83,2% (n = 154) de los ser-vicios de farmacia hospitalarios no realizaban actividades de atención farmacéutica no presencial con telefarmacia que incluyeran envío de medicación antes del inicio de la crisis sanitaria. En el periodo de estudio se atendieron 119.972 pacientes y se realizaron 134.142 envíos de medicación. La mayoría de los hospitales no utilizaron criterios de selección de pacientes. El 30,2% de los centros seleccionaron en función de las circunstancias personales del paciente. La dispensación domiciliaria y entrega informada (87%; 116.129 envíos) fue la opción utilizada de forma mayoritaria para el envío. Los medios para hacer llegar la medicación fueron, principalmente, la mensajería externa (47%; 87 centros) o medios propios del hospital (38,4%; 71 centros). Un 87,6% de los hospitales realizaron teleconsulta previa al envío de medicación y el 59,6% registró la actividad de telefarmacia en la agenda de citación. CONCLUSIONES: La implantación de la telefarmacia aplicada a la atención a pacientes externos en España durante la pandemia ha sido elevada. Así se ha podido garantizar la continuidad de los tratamientos de un elevado número de pacientes

OBJECTIVE: To analyze the status of the implementation and development of telepharmacy as applied to the pharmaceutical care of outpatients treated at hospital pharmacy services in Spain during the COVID-19 pandemic. METHOD: Six weeks after the beginning of the confinement period, an online 10-question survey was sent to all members of the Spanish Society of Hospital Pharmacists. A single response per hospital was requested. The survey included questions on the provision of remote pharmaceutical care prior to the onset of the health crisis, patient selection criteria, procedures for home delivery of medications and the means used to deliver them, the number of patients who benefited from telepharmacy, and the number of referrals made. Finally, respondents were asked whether a tele-consultation was carried out before sending patients their medication and whether these deliveries were recorded. RESULTS: A total of 39.3% (n = 185) of all the hospitals in the National Health System (covering all of Spain's autonomous regions) responded to the survey. Before the beginning of the crisis, 83.2% (n = 154) of hospital pharmacy services did not carry out remote pharmaceutical care activities that included telepharmacy with remote delivery of medication. During the study period, 119,972 patients were treated, with 134,142 deliveries of medication being completed. Most hospitals did not use patient selection criteria. A total of 30.2% of hospitals selected patients based on their personal circumstances. Home delivery and informed delivery (87%; 116,129 deliveries) was the option used in most cases. The means used to deliver the medication mainly included the use of external courier services (47.0%; 87 hospitals) or the hospital's own transport services (38.4%; 71 hospitals). As many as 87.6% of hospitals carried out teleconsultations prior to sending out medications and 59.6% recorded their telepharmacy activities in the hospital pharmacy appointments record. CONCLUSIONS: The rate of implementation of telepharmacy in outpatient care in Spain during the study period in the pandemic was high. This made it possible to guarantee the continuity of care for a large number of patients

Identifying and Prioritizing Effective Factors on Outsourcing in Public Hospitals Using Fuzzy BWM.

The outsourcing of health services has gained prominence over the past decades. Because numerous factors affect outsourcing in the field of health services, identifying and prioritizing these factors is specifically important. This study sought to identify and prioritize the factors affecting outsourcing, and to propose a model for the effective outsourcing of hospital services in Shiraz, Iran. The study drew on an exploratory mixed research method. In the first stage, all the criteria affecting the outsourcing of activities in hospitals were identified through the theoretical framework, a literature review, and interviews with hospital experts. Next, the criteria were finalized and prioritized using the fuzzy best-worst method (BWM). Following the literature review, 34 criteria for outsourcing were identified based on the studies explored and the interviews with the experts; the criteria were categorized into seven dimensions including "strategy", "management", "economy", "quality", "security and keeping patients' records", "service", and "agility." These dimensions formed the final outsourcing model of hospitals in Shiraz. Finally, the fuzzy BWM analysis revealed that "security and keeping patient's records" had the highest priority in outsourcing-related decision-making. The findings can help hospital managers make the right decision concerning the outsourcing of hospital services. The dimensions found in this research might also have been identified in other models, although this study was different in that it concentrated on the criteria in the specialized area of hospital management, while identifying the importance and weights of all the criteria involved.

One lab, two firms, many possibilities: On R&D outsourcing in the biopharmaceutical industry.

We draw from documented characteristics of the biopharmaceutical industry to construct a model where two firms can choose to outsource R&D to an external unit, and/or engage in internal R&D, before competing in a final market. We investigate the distribution of profits among market participants, and the incentives to coordinate outsourcing activities or to integrate R&D and production. Consistent with the empirical evidence, we find that the sign and magnitude of an aggregate measure of direct (inter-firm) and indirect (through the external unit) technological externalities drives the distribution of industry profits, with higher returns to the external unit when involved in development (clinical trials) than in early-stage research (drug discovery). In the latter case, the delinkage of investment incentives from industry value, together with the ability of firms to transfer risks to the external unit, imply a vulnerability of early-stage investors' returns to negative shocks, and the likely abandonment of projects with economic and medical value. We also find that competition in the equity market makes a buyout by one of the two firms more profitable to a research biotech than to a clinical services unit, and can stimulate early-stage investments. However, this long-term incentive can be minimal, notably if the superior efficiency of outsourced operations originates from economies of scope that can hardly be exploited when a firm takes control of the external unit exclusively for itself. R&D outsourcing thus does not always qualify as a relevant pathway to address the declining productivity in innovation that has characterized the industry over several decades.

Outsourcing an Effective Postdischarge Call Program: A Collaborative Approach.

To improve patient satisfaction ratings and decrease readmissions, many organizations utilize internal staff to complete postdischarge calls to recently released patients. Developing, implementing, monitoring, and sustaining an effective call program can be challenging and have eluded some of the renowned medical centers in the country. Using collaboration with an outsourced vendor to bring state-of-the-art call technology and staffed with specially trained callers, health systems can achieve elevated levels of engagement and satisfaction for their patients postdischarge.

Purchased Behavioral Health Care Received by Military Health System Beneficiaries in Civilian Medical Facilities, 2000-2014.

Introduction: Behavioral health conditions are a significant concern for the U.S. military and the Military Health System (MHS) because of decreased military readiness and increased health care utilization. Although MHS beneficiaries receive direct care in military treatment facilities, a disproportionate majority of behavioral health treatment is purchased care received in civilian facilities. Yet, limited evidence exists about purchased behavioral health care received by MHS beneficiaries. This longitudinal study (1) estimated the prevalence of purchased behavioral health care and (2) identified patient and visit characteristics predicting receipt of purchased behavioral health care in acute care facilities from 2000 to 2014. Materials and Methods: Medical claims with Major Diagnostic Code 19 (mental disorders/diseases) or 20 (alcohol/drug disorders) as primary diagnoses and TRICARE as the primary/secondary payer were analyzed for MHS beneficiaries (n = 17,943) receiving behavioral health care in civilian acute care facilities from January 1, 2000, to December 31, 2014. The primary dependent variable, receipt of purchased behavioral health care, was modeled for select mental health and substance use disorders from 2000 to 2014 using generalized estimating equations. Patient characteristics included time, age, sex, and race/ethnicity. Visit types included inpatient hospitalization and emergency department (ED). Time was measured in days and visits were assumed to be correlated over time. Behavioral health care was described by both frequency of patients and visit type. The University of South Carolina Institutional Review Board approved this study. Results: From 2000 to 2014, purchased care visits increased significantly for post-traumatic stress disorder, adjustment, anxiety, mood, bipolar, tobacco use, opioid/combination opioid dependence, nondependent cocaine abuse, psychosocial problems, and suicidal ideation among MHS beneficiaries. The majority of care was received for mental health disorders (78.8%) and care was most often received in EDs (56%). Most commonly treated diagnoses included mood, tobacco use, and alcohol use disorders. ED visits were associated with being treated for anxiety (excluding post-traumatic stress disorder; Adjusted odds ratio [AOR]: 9.14 [95% confidence interval (CI): 8.26, 10.12]), alcohol use disorders (AOR = 1.67 [95% CI: 1.53, 1.83]), tobacco use (AOR = 1.16 [95% CI: 1.06, 1.26]), nondependent cocaine abuse (AOR = 5.47 [95% CI: 3.28, 9.12]), nondependent mixed/unspecified drug abuse (AOR = 7.30 [95% CI: 5.11, 10.44]), and psychosis (AOR = 1.38 [95% CI: 1.20, 1.58]). Compared with adults age 60 yr and older, adolescents (ages 12-17 yr), and adults under age 60 yr were more likely to be treated for suicidal ideation, adjustment, mood, bipolar, post-traumatic stress disorder, nondependent cocaine, and mixed/unspecified drug abuse. Adults under age 60 yr also had increased odds of being treated for tobacco use disorders, alcohol use disorders, and opioid/combination opioid dependence compared with adults age 60 yr and older. Conclusions: Over the past 15 yr, purchased behavioral health care received by MHS beneficiaries in acute care facilities increased significantly. MHS beneficiaries received the majority of purchased behavioral health care for mental health disorders and were treated most often in the ED. Receiving behavioral health care in civilian EDs raises questions about access to outpatient behavioral health care and patient-centered care coordination between civilian and military facilities. Given the influx of new Veterans Health Administration users from the MHS, findings have implications for military, veteran, and civilian facilities providing behavioral health care to military and veteran populations.

Efficient and secure outsourcing of genomic data storage.

BACKGROUND: Cloud computing is becoming the preferred solution for efficiently dealing with the increasing amount of genomic data. Yet, outsourcing storage and processing sensitive information, such as genomic data, comes with important concerns related to privacy and security. This calls for new sophisticated techniques that ensure data protection from untrusted cloud providers and that still enable researchers to obtain useful information. METHODS: We present a novel privacy-preserving algorithm for fully outsourcing the storage of large genomic data files to a public cloud and enabling researchers to efficiently search for variants of interest. In order to protect data and query confidentiality from possible leakage, our solution exploits optimal encoding for genomic variants and combines it with homomorphic encryption and private information retrieval. Our proposed algorithm is implemented in C++ and was evaluated on real data as part of the 2016 iDash Genome Privacy-Protection Challenge. RESULTS: Results show that our solution outperforms the state-of-the-art solutions and enables researchers to search over millions of encrypted variants in a few seconds. CONCLUSIONS: As opposed to prior beliefs that sophisticated privacy-enhancing technologies (PETs) are unpractical for real operational settings, our solution demonstrates that, in the case of genomic data, PETs are very efficient enablers.

Effect of Transition From a Unit-Based Team to External Transport Team for a Pediatric Critical Care Unit.

OBJECTIVE: Pediatric hospitals must consider staff, training, and direct costs required to maintain a pediatric specialized transport team, balanced with indirect potential benefits of marketing and referral volume. The effect of transitioning a unit-based transport team to an external service on the pediatric intensive care unit (PICU) is unknown, but information is needed as hospital systems focus on population management. We examined the impact on PICU transports after transition to an external transport vendor. METHODS: Single-center retrospective review performed of PICU admissions, referrals, and transfers during baseline, post-, and maintenance period with a total of 9-year follow-up. Transfer volume was analyzed during pre-, post-, and maintenance phase with descriptive statistics and statistical process control charts from 1999 to 2012. RESULTS: Total PICU admissions increased with an annual growth rate of 3.7%, with mean annual 626 admissions prior to implementation to the mean of 890 admissions at the end of period, P < .001. The proportion of transport to total admissions decreased from 27% to 21%, but mean annual transports were unchanged, 175 to 183, P = .6, and mean referrals were similar, 186 to 203, P = .8. Seasonal changes in transport volume remained as a predominant source of variability. Annual transport refusals increased initially in the postimplementation phase, mean 11 versus 33, P < .03, but similar to baseline in the maintenance phase, mean 20/year, P = .07. Patient refusals were due to bed and staffing constraints, with 7% due to the lack of transport vendor availability. CONCLUSION: In a transition to a regional transport service, PICU transport volume was maintained in the long-term follow-up and total PICU admissions increased. Further research on the direct and indirect impact of transport regionalization is needed to determine the optimal cost-benefit and quality of care as health-care systems focus on population management.

Bioanalytical method transfer considerations of chromatographic-based assays.

Bioanalysis is an important part of the modern drug development process. The business practice of outsourcing and transferring bioanalytical methods from laboratory to laboratory has increasingly become a crucial strategy for successful and efficient delivery of therapies to the market. This chapter discusses important considerations when transferring various types of chromatographic-based assays in today's pharmaceutical research and development environment.

Outsourcing vaccine logistics to the private sector: The evidence and lessons learned from the Western Cape Province in South-Africa.

With few exceptions, immunization supply chains in developing countries continue to face chronic difficulties in providing uninterrupted availability of potent vaccines up to service delivery levels, and in the most efficient manner possible. As these countries struggle to keep pace with an ever growing number of vaccines, more and more Ministries of Health are considering options of engaging the private sector to manage vaccine storage, handling and distribution on their behalf. Despite this emerging trend, there is limited evidence on the benefits or challenges of this option to improve public supply chain performance for national immunization programmes. To bridge this knowledge gap, this study aims to shed light on the value proposition of outsourcing by documenting the specific experience of the Western Cape Province of South Africa. The methodology for this review rested on conducting two key supply chain assessments which allowed juxtaposing the performance of the government managed segments of the vaccine supply chain against those managed by the private sector. In particular, measures of effective vaccine management best practice and temperature control in the cold chain were analysed. In addition, the costs of engaging the private sector were analysed to get a better understanding of the economics underpinning outsourcing vaccine logistics. The results from this analysis confirmed some of the theoretical benefits of outsourcing to the private sector. Yet, if the experience in the Western Cape can be deemed a successful one, there are several policy and practice implications that developing countries should be mindful of when considering engaging the private sector. While outsourcing can help improve the performance of the vaccine supply chain, it has the potential to do the reverse if done incorrectly. The findings and lessons learnt from the Western Cape experience can serve as a step towards understanding the role of the private sector in immunization supply chain and logistics systems for developing countries.

Outsourcing cytological samples to a referral laboratory for EGFR testing in non-small cell lung cancer: does theory meet practice?

OBJECTIVE: Guidelines from the College of American Pathologists (CAP), the International Association for the Study of Lung Cancer (IASLC) and the Association for Molecular Pathology (AMP) consider cytology suitable for testing epidermal growth factor receptor (EGFR) mutations in lung adenocarcinoma. The guidelines recommend that cytopathologists first discuss the possibility of testing squamous cell carcinomas (SqCC) in multidisciplinary meetings. Second, cell blocks should be analysed rather than smear preparations and, third, specimens should be sent to external molecular laboratories within three working days of receiving requests. This study monitored how these recommendations are met in practice. METHODS: Our laboratory received 596 requests from cytologists from 13 different institutions. For each case, the cytological diagnosis, cytopreparation type, and time between the request and sample mailing were compared with the recommendations. RESULTS: Of the 596 samples, 32 (5.4%) had been reported as SqCC. Three of these (9.4%) showed EGFR mutation. Cytological slides, either ThinPrep(™) (51.2%) or direct smears (43.2%), were more frequently received than cell blocks (5.7%). The mean time between the oncologist's request and specimen dispatching was 5.8 working days. CONCLUSIONS: The occurrence of mutations in samples reported as SqCC was higher than expected. This questions the reliability of the original diagnosis, which reinforced the recommendation to evaluate the opportunity for testing non-adenocarcinoma cytology on a case-by-case basis. In spite of CAP/IASLC/AMP recommendations, cell blocks were underutilized for EGFR testing, but cytological slides were suitable for DNA analyses. Significant efforts are needed to avoid delays in outsourcing cytological samples for EGFR testing.

Risk management for outsourcing biomedical waste disposal - using the failure mode and effects analysis.

Using the failure mode and effects analysis, this study examined biomedical waste companies through risk assessment. Moreover, it evaluated the supervisors of biomedical waste units in hospitals, and factors relating to the outsourcing risk assessment of biomedical waste in hospitals by referring to waste disposal acts. An expert questionnaire survey was conducted on the personnel involved in waste disposal units in hospitals, in order to identify important factors relating to the outsourcing risk of biomedical waste in hospitals. This study calculated the risk priority number (RPN) and selected items with an RPN value higher than 80 for improvement. These items included "availability of freezing devices", "availability of containers for sharp items", "disposal frequency", "disposal volume", "disposal method", "vehicles meeting the regulations", and "declaration of three lists". This study also aimed to identify important selection factors of biomedical waste disposal companies by hospitals in terms of risk. These findings can serve as references for hospitals in the selection of outsourcing companies for biomedical waste disposal.

Strategies for successful revenue cycle outsourcing.

Revenue cycle outsourcing can offer hospitals and health systems many advantages, including cost savings and revenue gains, but it also carries risks. Some organizations may choose to outsource revenue cycle to third-party service providers; others may opt to develop internal centers of excellence. Hospitals and health systems should consider IT system compatibility, payment arrangements, and incentive and value alignment when selecting an outsourcing partner.