Specialized Hospital Setting Research Articles

Evaluation of Patient Experience With A Model of Coordinated Telematic Pharmaceutical Care Between Hospital and Rural Pharmacies in Spain: A Proof of Concept.

To determine the usefulness of a coordinated pharmaceutical care model between the specialized hospital setting and the rural community care setting, based on the incorporation of telepharmacy based on Capacity-Motivation-Opportunity (CMO) methodology to improve patient experience with hospital medication prescriptions. Prospective cohort study in outpatients receiving telepharmacy based on CMO-based pharmaceutical care in rural areas in Spain between January and November 2021, conducted by the pharmacy department of four hospitals and 29 rural communities' pharmacy. Each patient was followed for 48 weeks on both face-to-face and telematic visits, scheduled and unscheduled at the patients' request. Patient experience (IEXPAC questionnaire), and satisfaction (EVASAF) were determined. Secondary variables included pharmaceutical care interventions, care coordination and clinical variables (compliance with pharmacotherapeutic objectives according to the clinical conditions of each patient), additionally measurement of individual holistic results (EQ5D-5L score) was evaluated. A new telepharmacy tool (called Telemaco) was developed for a multidisciplinary healthcare team (available at: https://inteligeniapps.com/telemaco/) that includes seven different functionalities. We evaluated the first 20 patients (50% women) were included. Their median age was 66.0 years (IQR=14). A total of 215 visits were made (adding 150 video calls). A total of 64 visits were unscheduled (29.7%). The patient´s experience showed improvement (7.4 vs 9.5, p<0.005). The results of the EVASAF questionnaire were also higher (44 vs 48, p<0.001). Overall, 573 pharmaceutical interventions were performed. A difference was observed in patients who achieved the intended pharmacotherapeutic objectives: 48.5 vs 88.2 (p< 0.001). The mean EQ-5D-5L score was 74.7 ± 3.3 at baseline and 80.6 ± 3.6 points at the end (p>0.05). Telepharmacy based on the CMO-PC model, using the "Telemaco" tool, has improved the patient experience, satisfaction, and offered other advantages over the traditional model, including more pharmaceutical interventions adapted to the needs of each patient.

Use of serum amyloid A in equine medicine and surgery.

Serum amyloid A (SAA) has become an indispensable part of the management of equine patients in general practice and specialized hospital settings. Although several proteins possess acute phase properties in horses, the usefulness of SAA exceeds that of other acute phase proteins. This is due to the highly desirable kinetics of the equine SAA response. SAA concentrations exhibit a rapid and pronounced increase in response to inflammation and a rapid decline after the resolution of inflammation. This facilitates the detection of inflammatory disease and real-time monitoring of inflammatory activity. SAA may be used in all stages of patient management: (1) before diagnosis (to rule in/rule out inflammatory disease), (2) at the time of diagnosis (to assess the severity of inflammation and assist in prognostication), and (3) after diagnosis (to monitor changes in inflammatory activity in response to therapy, with relapse of disease, or with infectious/inflammatory complications). By assessing other acute phase reactants in addition to SAA, clinicians can succinctly stage inflammation. White blood cell counts and serum iron concentration change within hours of an inflammatory insult, SAA within a day, and fibrinogen within 2-3 days; the interrelationship of these markers thus indicates the duration and activity of the inflammatory condition. Much research on the equine SAA response and clinical use has been conducted in the last decade. This is the prerequisite for the evidence-based use of this analyte. However, still today, most published studies involve a fairly low number of horses. To obtain solid evidence for use of SAA, future studies should be designed with larger sample sizes.

Association of preoperative glucose concentration with mortality in patients undergoing craniotomy for brain tumor.

Hyperglycemia is associated with worse outcomes in ambulatory settings and specialized hospital settings, but there are sparse data on the importance of preoperative blood glucose measurement before brain tumor craniotomy. The authors sought to investigate the association between preoperative glucose level and 30-day mortality rate in patients undergoing brain tumor resection. This retrospective cohort study included patients undergoing craniotomy for brain tumors at West China Hospital, Sichuan University, from January 2011 to March 2021. Surgical mortality rates were evaluated in patients who had normal glycemia (< 5.6 mmol/L) as well as mild (5.6-6.9 mmol/L), moderate (7.0-11.0 mmol/L), and severe hyperglycemia (> 11.0 mmol/L). The study included 12,281 patients who underwent tumor resection via craniotomy. The overall 30-day mortality rate was 2.0% (242/12,281), whereas the rates for normal glycemia and mild, moderate, and severe hyperglycemia were 1.5%, 2.5%, 3.8%, and 6.5%, respectively. Compared with normal glycemia, the odds of mortality at 30 days were higher in patients with mild hyperglycemia (adjusted odds ratio [OR] 1.44, 95% confidence interval [CI] 1.05-2.00), moderate hyperglycemia (OR 2.04, 95% CI 1.41-2.96), and severe hyperglycemia (OR 3.76, 95% CI 1.96-7.20; p < 0.001 for trend). When blood glucose was analyzed as a continuous variable, for each 1 mmol/L increase in blood glucose, the adjusted OR of 30-day mortality was 1.13 (95% CI 1.08-1.19). The addition of a preoperative glucose level significantly improved the area under the curve and categorical net reclassification index for prediction of mortality. In patients undergoing craniotomy for brain tumors, even mild hyperglycemia was associated with an increased mortality rate, at a glucose level that was much lower than the commonly applied level.

Development of Medication Administration Protocols for In-Home Pediatric Feeding Cases.

Medication administration can be a significant issue in pediatric populations, and especially with patients with developmental disabilities and comorbid feeding disorders. Research has focused largely on consumption of solids rather than medication and liquids in pediatric feeding programs, with most studies being conducted within specialized hospital settings in the United States. No studies to our knowledge have detailed treatment evaluations for medication administration in pediatric feeding except for a few studies on pill swallowing. We report results of treatment protocols for medication administration using empirically-supported treatments in a short-term intensive home-based behavior-analytic program in Australia. Two males with autism spectrum and pediatric feeding disorders participated. We used a multiple baseline single-case experimental design for medication administration conducted concurrently with a treatment evaluation for solid foods. Consumption increased in number (9; supplements, laxatives, pain relievers), flavors (8; chocolate, blackcurrent and apple, strawberry, lemon-lime, orange, chocolate-vanilla, cherry, apple), forms (4; thin and thick liquids, chewables, gummies), and delivery methods (5; finger-fed, spoon, cup, medicine spoon, medicine cup) within the first treatment session. For one participant, we taught open cup drinking for a variety of liquids (milk, juices, medications). For both participants, we taught self-feeding with utensils for thick liquid medications. Treatment results were similar for solids and participants increased food variety to over 160 across food groups. All goals were met including training parents to maintain gains at home.

Explainable Artificial Intelligence and Wearable Sensor-Based Gait Analysis to Identify Patients with Osteopenia and Sarcopenia in Daily Life.

Osteopenia and sarcopenia can cause various senile diseases and are key factors related to the quality of life in old age. There is need for portable tools and methods that can analyze osteopenia and sarcopenia risks during daily life, rather than requiring a specialized hospital setting. Gait is a suitable indicator of musculoskeletal diseases; therefore, we analyzed the gait signal obtained from an inertial-sensor-based wearable gait device as a tool to manage bone loss and muscle loss in daily life. To analyze the inertial-sensor-based gait, the inertial signal was classified into seven gait phases, and descriptive statistical parameters were obtained for each gait phase. Subsequently, explainable artificial intelligence was utilized to analyze the contribution and importance of descriptive statistical parameters on osteopenia and sarcopenia. It was found that XGBoost yielded a high accuracy of 88.69% for osteopenia, whereas the random forest approach showed a high accuracy of 93.75% for sarcopenia. Transfer learning with a ResNet backbone exhibited appropriate performance but showed lower accuracy than the descriptive statistical parameter-based identification result. The proposed gait analysis method confirmed high classification accuracy and the statistical significance of gait factors that can be used for osteopenia and sarcopenia management.

Hospital acquired COVID-19 infections amongst patients before the rollout of COVID-19 vaccinations, a scoping review

BackgroundHospital settings are at increased risk of spreading Coronavirus Disease 2019 (COVID-19) infections, hence non-pharmaceutical prevention interventions (NPPIs) and prioritized vaccination of healthcare workers and resident patients are critical. The status of COVID-19 hospital acquired infections (HAIs) in low-income settings is unclear. We aimed to identify and summarize the existing evidence on COVID-19 HAIs amongst patients, prior to the rollout of vaccines in countries worldwide.MethodsWe conducted a scoping review of English peer-reviewed literature in PubMed, Web of Science and Scopus using a combination of selected search terms. Full texts articles presenting results on COVID-19 HAIs in hospitalised patients before the rollout of vaccines in countries worldwide were eligible. Data extracted from eligible articles included estimates of COVID-19 HAIs, country, and type of hospital setting, and was summarized narratively. Quality assessment of included articles was not possible.ResultsLiterature searches generated a total of 5920 articles, and 45 were eligible for analysis. Eligible articles were from Europe, North America, Asia, and Brazil and none were from low-income countries. The proportion of COVID-19 HAIs ranged from 0% when strict NPPIs were applied, to 65% otherwise. The estimates of COVID-19 HAIs did not differ by country but were lower in studies conducted after implementation of NPPIs and in specialized hospital settings for operative surgery. Studies conducted before the implementation of NPPIs or in long-term care and psychiatric wards often reported high estimates of HAI. Although there was no clear trend in general wards, those situated in academic hospitals managed to reduce HAI rates under strict NPPI protocols. Operative surgery settings, unlike psychiatric settings, effectively prevented COVID-19 HAI using tailored NPPIs.ConclusionThe available evidence shows a high risk of COVID-19 HAIs, the feasibility of preventing HAIs in different healthcare settings and the importance of appropriately tailored NPPIs. There were no data from low-income settings, therefore, it is unclear whether the reported NPPI approaches could be equally effective elsewhere. We recommend routine monitoring of COVID-19 HAIs in countries with low vaccination coverage, to identify and close gaps in NPPIs and understand gains made from vaccinating healthcare workers and hospitalized patients.

Adiponectin predicts poor response to antidepressant drugs in major depressive disorder.

Produced by adipocytes, adiponectin crosses the blood-brain barrier to bind with specific receptors in the hypothalamus, brainstem, hippocampus, and cortex. In patients with major depressive disorder (MDD), circulating levels of adiponectin inversely related with antidepressant response to ketamine, and predicted a better response to multi-target drug combinations than to escitalopram. We investigated the effect of adiponectin on response to antidepressants in a naturalistic setting. We assessed baseline plasma levels of adiponectin in 121 MDD inpatients, treated with antidepressant drug monotherapy based on clinical need (selective serotonin reuptake inhibitors, venlafaxine, duloxetine) in a specialized hospital setting. Severity of depression was weekly assessed with Hamilton scale ratings. Adiponectin plasma levels were higher in patients with MDD compared with healthy controls, and negatively influenced the pattern of antidepressant response (higher baseline levels, worse response) independent of the drug class and of the baseline severity of depression, and of age, sex, and body mass index. The identification of adiponectin as a predictor of antidepressant response to drugs of different mechanism of action, such as ketamine, SSRIs, and SNRIs, and both in experimental and in clinical settings, warrants interest for further study of its pathways to search for novel biomarkers and therapeutic targets.

What a weight loss programme should contain if people with obesity were asked - a qualitative analysis within the DO:IT study

BackgroundCurrently 1.9 billion adults worldwide are estimated to be overweight or obese. In Denmark the municipalities hold the responsibility to deliver weight loss programmes to overweight and obese citizens. There is a tendency to assume that weight loss programmes that show positive effects in specialized hospital settings are directly transferrable to municipal settings. However, municipality-based weight loss programmes have not produced clinically significant reductions in body weight. One reason for this may be that much research evidence regarding obesity programming neglects the perspectives of people with obesity. The first step in developing a weight loss programme designed for municipal settings is to understand what people with obesity want and need from a programme. The aim of this study was to examine what people with obesity find important in a weight loss programme for weight loss and weight maintenance.MethodsWe used a qualitative, explorative, descriptive design with individual interviews. We included men and women age 17 and older with a BMI ≥ 25 kg/m2. Participants were recruited from the wait lists of 13 municipality programmes and through Facebook posts. Data were analyzed using content analysis.ResultsThirty-four participants with overweight or obesity were individually interviewed (ages between 19 and 74). Findings suggest that weight loss programmes should; a) support participants in structuring days; b) consider the use of replacement activities to reduce cognitive and emotional burden; c) aide individuals to increase self-efficacy and; d) include family and friends as well as health professionals and peers in the weight loss process. Diet and exercise, while important, should be balanced with other meaningful activities in everyday life.ConclusionParticipants in this study wished to balance weight loss related activities with overall everyday life as well as finding the believe in their ability to lose weight in social relations.

Effects of Mindfulness-Based Stress Reduction Training on Healthcare Professionals' Mental Health: Results from a Pilot Study Testing Its Predictive Validity in a Specialized Hospital Setting.

This pilot study aimed to evaluate the feasibility and acceptability of a Mindfulness-Based Stress Reduction (MBSR) training and to examine positive and negative symptom-focused mental health variables. The mental health variables were used to test the predictive validity of the training among healthcare professionals. Thirty healthcare professionals participated in this non-randomized pre-post intervention pilot study. The questionnaire on mental health was filled in twice. Baseline and post-intervention differences were tested with paired samples t-tests and Wilcoxon signed-rank tests. The participants’ evaluation of the training was assessed with a five-item questionnaire. The recruitment and retention were successful, and participants’ evaluation of the training itself was positive but the influence on daily life was rated only moderately positive. In comparison with baseline at post-intervention participants showed significant improvements in general mindfulness, the burnout dimension personal accomplishment, quality of sleep, positive emotions, and self-efficacy. A significant decrease was found in the burnout dimension emotional exhaustion, stress level, negative emotions at work, and worrying. No significant changes were found for the burnout dimension mental distance, and work engagement. The measures showed ample within-person differences and low, medium, or high effect sizes. The current trial approach of the MBSR training seems feasible and acceptable. Our results suggest that mindfulness, burnout, stress level, quality of sleep, positive emotions at work, negative emotions at work, self-efficacy, and worrying are meaningful mental health variables for inclusion in a larger-scale Randomized Controlled Trial on the effects of MBSR.

General Practitioner Attendance in Proximity to HPV Vaccination: A Nationwide, Register-Based, Matched Case-Control Study.

AimThis study aimed to describe and compare general practitioner (GP) attendance patterns in the years surrounding HPV-vaccination among cases suspected to experience adverse events and their matched controls in order to determine if a potential larger change in GP attendance among cases was observed in temporal relation to vaccination.MethodsRegister-based, matched case–control study. Cases were defined as women referred to specialized hospital settings (HPV-centers) for suspected adverse event between June 1st 2015 and December 31st 2015 (n=1458). Information on referral was obtained from the HPV-centers directly. Each case was matched with five controls on age at vaccination, region, time of first vaccine registration and total number of doses, resulting in a total study population of 8670 girls and women. Negative binomial regression analyses were used (i) to estimate mean yearly GP contacts among cases and controls, and (ii) to further investigate the relative difference in change in GP attendance following vaccination between cases and controls.ResultsOverall, cases displayed higher GP attendance than controls from five years before vaccination up until five years after. Compared to controls, cases increased their GP attendance more in the years following HPV vaccination, corresponding to a 40% increase in the incidence rate ratios (IRR) from before to after vaccination (ratio-IRR = 1.40 [1.36; 1.44]). The change occurred in close proximity to vaccination, and the pattern was the same independently of the year of vaccination. However, for the later vaccination years cases displayed an additional increase in their GP attendance around time of extensive media attention.ConclusionGirls and women being referred for suspected adverse events after HPV-vaccination changed their GP attendance pattern in close proximity to their first HPV-vaccination and not solely in temporal linkage to the onset of public debate.

Side Deposit with Regular Texture Food for Clinical Cases In-Home.

Objective Research has shown effectiveness of nonremoval of the spoon and physical guidance in increasing consumption and decreasing inappropriate mealtime behavior. The side deposit has been used to treat passive refusal in 2 studies (1 in a highly specialized hospital setting) using lower manipulated-texture foods on an infant gum brush. Methods We extended the literature by using regular texture bites of food with a finger prompt and side deposit (placing bites inside the side of the child's mouth via the cheek) in an intensive home-based program setting in Australia, demonstrating that attention and tangible treatments alone were ineffective prior, fading the tangible treatment, showing caregiver training, and following up. 2 male children with autism spectrum disorder (with texture/variety selectivity; one with liquid dependence) participated in their homes. We used a reversal design to replicate effectiveness of the side deposit added to a treatment package. Results For both participants, we observed a >98% decrease in latency to acceptance, a 100% decrease in inappropriate mealtime behavior, and a 100% increase in consumption with the side deposit added. Variety was increased to over 85 regular texture foods. 100% of admission goals were met. Caregivers were trained to high procedural integrity and the protocol was generalized to school and the community. Gains maintained to 3 and 1.5 years. Conclusion This is important work in adding to the literature and support for the side deposit and expanding to regular texture, as well as replicating and extending empirically supported treatments for feeding internationally to the home setting.

Hospital contacts and diagnoses five years prior to HPV vaccination among females referred for suspected adverse vaccine effects: A Danish nationwide case-control study

BackgroundHigh health care utilization before Human Papilloma Virus (HPV) vaccination might be associated with increased risk of suspected adverse effects (AE’s) after vaccination. We investigated the association between hospital contacts and diagnoses before HPV vaccination and risk of later referral to a specialized hospital setting (HPV center) for suspected AE’s. MethodsThe study was a Danish register-based matched case-control study. Cases were females referred to an HPV center. Five controls per case were randomly selected in the source population of HPV vaccinated females. Information on hospital contacts and diagnoses was obtained from the Danish National Patient Registry. Conditional logistic regression analyses were used to investigate the association between having one or more diagnoses in each specific International Classification of Diseases 10th version (ICD-10) chapter five years before the HPV vaccination and subsequent referral to an HPV center. ResultsWe identified 1496 cases and 7480 controls. In total, 80% of the cases versus 65% of the controls had at least one hospital contact prior to HPV vaccination (Prevalence Proportion Ratio - PPR: 1.24 (95% Confidence Interval - CI: 1.21–1.27)), with 24% vs 12% (PPR: 1.97 (95% CI: 1.76–2.19)) having six or more contacts. Cases were more likely to have had a diagnosis in 15 out of 19 ICD-10 chapters before the vaccination, with ORs larger than 1.8 for infectious diseases, psychiatric diseases, diseases of the nervous, circulatory, digestive and musculoskeletal system, unspecific symptoms and unspecific contacts. ConclusionPre-vaccination morbidity and health care utilization seem to play a role in the path leading to suspected AE’s after HPV vaccination. Since many of the diagnoses that were particularly increased before vaccination in referred females are overlapping with the most frequent symptoms reported, we cannot exclude that for some of the females, the suspected AE’s might have been existing already before the vaccination.

Psychiatric conditions and general practitioner attendance prior to HPV vaccination and the risk of referral to a specialized hospital setting because of suspected adverse events following HPV vaccination: a register-based, matched case-control study.

AimNo association between human papilloma virus (HPV) vaccination and numerous diseases has been found. Still, a large number of Danish women are reporting suspected adverse events. Other factors may play a role, and the aim of this study is to examine the association between psychiatric conditions, general practitioner (GP) attendance and indicators of psychological symptoms prior to HPV vaccination and the risk of referral to an HPV center following vaccination.Study design and settingRegister-based, matched case–control study. Cases were identified from five Danish, regional HPV centers, and health data for cases and controls were obtained from national registries.ParticipantsCases were defined as women referred to an HPV center between January 1, 2015 and December 31, 2015 (n=1,496). Each case was matched with five controls on age, region and time of first vaccine registration. The total study population consisted of 8,976 women.ResultsOverall, women above 18 years who had been referred to an HPV center were more likely to have used psychiatric medication (odds ratio [OR]: 1.88 [95% CI 1.48–2.40]) or to have been hospitalized because of a psychiatric disorder within 5 years prior to the first vaccine registration (OR: 2.13 [95% CI 1.59–2.86]). Specifically, referred women were more likely to have used antipsychotics, antidepressants, attention deficit hyperactivity disorder (ADHD) medication or anxiolytics, and to have been hospitalized for affective disorders or anxiety, but not to have been hospitalized for schizoid, ADHD or eating disorders. In addition, they were more likely to have had talk therapy or psychometric test performed prior to vaccination (OR: 1.72 [95% CI 0.1.35–2.18] and OR: 1.67 [95% CI 1.30–2.13], respectively). Referred women of all ages had higher use of GP before vaccination. Population attributable fraction analyses indicated that psychiatric medication, hospitalization due to a psychiatric disorder and use of talk therapy, or psychometric test “explained” 13%, 10%, 12% and 11% of the referrals, respectively. Results did not change substantially when adjusted for potential confounders.ConclusionWomen referred to HPV centers because of suspected adverse events after vaccination more often had preexisting psychiatric conditions, psychological symptoms or frequent GP attendance prior to HPV vaccination.

Nurses' hospital orientation and future research challenges: an integrative review.

This study aimed to describe the research on registered nurses' orientation processes in specialized hospital settings in order to illustrate directions for future research. The complex healthcare environment and the impact of nursing shortage and turnover make the hospital orientation process imperative. There is a growing recognition regarding research interests to meet the needs for evidence-based, effective and economically sound hospital orientation strategies. An integrative literature review was performed on publications from the period 2000 to 2013 included in the CINAHL and PubMed databases. English-language studies were included. Themes guiding the analysis were definition of the hospital orientation process, research topics, data collection and instruments and research evidence. Narrative synthesis was used. Eleven papers met the inclusion criteria. The conceptualization of orientation process reflected the complexity of the phenomenon. Less attention has been paid to designs to establish correlations or relationships between selected variables and hospital orientation process. The outcomes of hospital orientation programmes were limited primarily to retention and job satisfaction. The research evidence therefore cannot be evaluated as strong. The lack of an evidence-based approach makes it difficult to develop a comprehensive orientation process. Further research should explore interventions that will enhance the quality of hospital orientation practices to improve nurses' retention and job satisfaction. To provide a comprehensive hospital orientation process, hospital administrators have to put in place human resource development strategies along with practice implications and research efforts. Comprehensive hospital orientation benefits and outcomes should be visible to policy makers.

Implementation of a Near-Peer Teaching Model in Pharmacy Education: Experiences and Challenges

There is an increasing demand for high-quality experiential placements for pharmacy students. As a result, pharmacy schools across Canada are confronted with the need to find innovative ways to expand experiential educational rotations. Near-peer teaching is one model with the potential to address this issue. Near-peer teaching involves the provision of learning support to junior students by their senior peers. This teaching methodology, which is common in many medical education programs, is thought to allow pharmacy students a unique learning environment for integrating pharmacy knowledge into pharmacy practice. It gives the student access to an additional potential learning environment without unduly increasing the preceptor’s workload. Although peer teaching has been well established in many health care communities, this approach has not been widely adopted in pharmacy education. This paper describes the experiences and challenges of this teaching model in pharmacy education within a specialized hospital setting.

Pediatric diabetic ketoacidosis management in the era of standardization

Up to 70% of children with new-onset Type 1 diabetes mellitus (T1DM) present with diabetic ketoacidosis (DKA), with most cases initially assessed by their primary care provider. DKA is the most common cause of death in children with T1DM, mainly related to cerebral edema that occurs at a frequency of 0.15–4.6%. Early recognition of DKA can be improved by increasing the awareness of early clinical symptoms such as enuresis, polyuria and polydipsia. Clinical acumen paired with early assessment of patients with suspected T1DM and known T1DM, particularly if risk factors for DKA are present, can prevent serious complications and fatal outcomes. Urgent referral to specialist centers for suspected new-onset T1DM/DKA is required. A standardized approach is recommended to be followed to ensure successful initial management of DKA, both in the nonspecialist setting before transfer and in the more specialized hospital setting. This article outlines such a management approach.

Pharmacovigilance of Biopharmaceuticals

Biopharmaceuticals are important treatment options for a variety of chronic and sometimes life-threatening diseases. Compared with the traditional small molecule drugs, biopharmaceuticals have specific characteristics, which might also influence their safety profile. They have, for example, a complex production process, limited predictability of preclinical to clinical data, a high potential for immunogenicity, and adverse events can often be related to an exaggerated pharmacology. The limited predictability of preclinical to clinical data and the known limitations of randomized controlled trials results in limited knowledge of the safety profile of biopharmaceuticals at the point of their approval, underlining the need for pharmacovigilance. Due to their specific characteristics, pharmacovigilance activities required for biopharmaceuticals might differ from those required for small molecules. This review discusses characteristics and potential challenges with the pharmacovigilance and risk management of biopharmaceuticals as compared with small molecules, and proposes remedies for some of the emerging problems. Spontaneous reporting of adverse drug reactions (ADRs) is important in the detection of new, rare and/or serious ADRs. However, causality assessment remains complicated because of concomitant diseases or drugs. This is particularly the case with biopharmaceuticals, as they are often indicated to treat severe and/or life-threatening diseases in patients who often have other diseases and are treated with concomitant medication. Proactive risk management has been implemented in the EU by the obligatory submission of an EU risk management plan (EU-RMP). In this, the (potential) risks should be described and pharmacovigilance activities proposed. Pharmacovigilance activities can be either routine or additional (post-authorization safety studies [PASS]) activities. During safety assessment, stakeholders are encouraged to use knowledge obtained with biopharmaceuticals with a comparable pharmacology. PASS of biopharmaceuticals with a comparable pharmacology may therefore be used to complement each other. Since biopharmaceuticals are often used in a specialized hospital setting, it is expected that large population-based databases will contain limited information on biopharmaceuticals. Registries have therefore been shown to be an important tool to obtain pharmacovigilance data. Since small changes in the production and purification process might alter the safety profile, activities to improve traceability of the specific biopharmaceutical responsible for the ADR should be taken into account. Key messages in safety management of biopharmaceuticals remain: be prepared for the unexpected, be aware of confounding by disease (severity) and maintain exposure ascertainment/traceability throughout the logistical chain.

Treatment Outcome for Adolescent Obsessive-Compulsive Disorder in a Specialized Hospital Setting

Although few data are available concerning adolescents with obsessive-compulsive disorder (OCD), the existing literature suggests that cognitive-behavioral therapy (CBT) is the first-line treatment of choice for adolescents with mild to moderate OCD. A combination of CBT and serotonin reuptake inhibitors (SRIs) is recommended for more severe forms of OCD, based on the Expert Consensus Guidelines for the Treatment of Obsessive-Compulsive Disorder and the Pediatric OCD Treatment Study (POTS). Despite the effectiveness of CBT, a recent meta-analysis found that 27% of adolescent outpatients fail to show clinically significant improvement following CBT and many also fail to show improvement with pharmacotherapy. One alternative for those who do not improve with outpatient treatment is an intensive inpatient program. Within the last 10 years, two specialty hospitals have created programs that provide intensive CBT milieu treatment with multidisciplinary support (e.g., nursing, psychopharmacology) to treat adolescents with OCD. This naturalistic study describes treatment outcomes in 23 patients who received treatment in one of these programs between 2005 and 2006. Results suggest significant improvements on the majority of outcome measures, with 70% of the patients judged to meet criteria for clinically significant change. Thus, inpatient treatment appears potentially efficacious, although future controlled trials with larger samples are needed.

The Primary Physician and the Death of a Child in a Specialized Hospital Setting

Pediatricians offer ongoing comprehensive and coordinate care for children. Community-based primary pediatricians assume a large proportion of this repsonsibility, referring a few patients to collegues with specialized skills for consultation and treatment. These consultants, who are often fulltime members of university or other medical centers, provide care extending the lives of many children suffering illnesses that formerly were fatal early in the course of the disease. Some infants and children unfortunately do die after many months or years of treatment at a specialized clinic or hospital service. When this tragedy occurs, parents and siblings have the difficult task of relinquishing their relationship to hospital physicians, nurses, and social workers who have sustained them for many months or years.