Keeping the Pace between Research and Clinical in Covid-19 Pandemic: A Psychological Experience in a High-Risk Pregnancy Ward

Background: From the literature emerges that having a pregnancy and especially a high-risk pregnancy in time of pandemic can lead to an increase of the levels of anxiety, which are usually already higher in relation to maternal-fetal disease. Furthermore, the literature shows that significant organizational and methodological changes have been introduced in the detection of psychological conditions, such as the introduction of telehealth intervention. Particularly in our experience about psychological health screenings there was a period of care interruption (between 11.03.2020 and 04.05.2020) and a clinical activity restructuring on the ward according to the new needs that have accrued. The aim of this experience is to analyze the progress of psychological health perinatal screening in women during the Covid-19. Specifically, we aimed to understand the percentage of positive screening and management compared to the pre-pandemic period. Method(s): Perinatal psychological screening was administered to women with high-risk pregnancy hospitalized in a Obstetric ward in a period between May 2020 to December 2021. The data were then compared with those recorded from September 2019 to February 2020 (pre-Covid-19). Screening consists in the description of the Obstetrical Psychology Service, the case history, the self-administration questionnaire GHQ-12 (General Health Questionnaire- 12) and the assessment interview if necessary. Result(s): A total of 469 screenings were administered during the pandemic, about 30% of which were found to be positive in the screenings (2020-21). Specifically in 2020, the positivity amounted to 28.69%. Of these 64 women, 56 performed the assessment, and in particular 22 were taken to the Psychology Service, 6 were referred to the territorial counseling centers, and 28 didn't receive further treatment indication. In 2021, the positivity was 32.93%. Especially of these 81 women, 32 were taken to the Psychology Service, 10 were sent to the territorial counseling centers and, 16 refused the assessment interview, 6 were already in treatment, 11 didn't receive further treatment indications and 6 cases dropped out. In the pre-pandemic phase the rate of positivity was 27%. Of the 30 women who tested positive at the screening, 5 were taken to the Psychology Service, 9 were referred to family counseling centers in the area, 11 refused the assessment interview, and 5 didn't receive further therapeutic indication. Conclusion(s): The importance of psychological care continuity and the feasibility of administering psychological health screenings clearly emerges in the ward despite the changed health situation due to Covid-19. The results show how the positivity rate for psychological health screening increases over the years (27% from September 2019 to February 2020/pre-Covid-19, 28,69% from May to December 2020 and 32,93% in 2021).

A feasibility trial of a computerised Spatial Inattention Grasping Home-based Therapy (c-SIGHT) for spatial neglect post-stroke: Trial update

Introduction: Spatial neglect (SN) is a debilitating neuropsychological syndrome defined as a failure to respond to stimuli in the side of space opposite to the side of the brain injury. Despite the impact, there are currently no clinically effective rehabilitation methods. Computerised rehabilitation can increase enjoyment and feelings of independence (Morse et al.,2020), thus we developed computerised Spatial Inattention Grasping Home-based Therapy (c-SIGHT) which can remotely record adherence and facilitate self-administration. SIGHT, or visuomotor feedback training, or (grasping-to-lift and balance rods) has been shown to be effective in reducing SN (Rossit et al., 2019). Method(s): This research aims to investigate the feasibility of a randomized controlled trial using c-SIGHT vs. an attentional control, while also exploring experiences of self-administering the therapy at home. This is a two-arm, double-blinded feasibility study intends to recruit 46 stroke survivors with SN and allocate them using minimisation to self-administer c-SIGHT or an attentional control for 30 minutes, twice a day for 10 days at home. Participants complete a set of neuropsychological tests and questionnaires at three time points (baseline, post-training, one-month follow-up) and one semi-structured interview after using c-SIGHT. Primary outcomes are feasibility parameters (recruitment, blinding success, adherence, follow-up rates). Secondary outcomes are changes in neglect, cognition and activities of daily living. Result(s): Since May 2021, the study has opened up at five NHS sites in the East of England. Despite COVID-19 delays, 20 stroke survivors have been recruited, 11 completed baseline assessments, and four have completed the study. Conclusion(s): Other preliminary results (e.g., usability) will be presented.

Severe asthma outcomes in patients self-administering biological therapy at home

Introduction: The use of biological therapy in eosinophilic and atopic asthma has grown exponentially over the last 14years. Treatment was initially hospital-based, but the COVID-19 pandemic has accelerated the implementation of patient homecare self-administration (HSA) of biologics. Aim(s): To assess the stability of patients transfered on HSA by comparing data from biologic initiation to HSA discharge and annual review. Result(s): This report includes 56 patients who attended for annual review between April and December 2021 (60% female, mean age 54 [SD13.4]) for Benralizumab (42.9%), Mepolizumab (35.7%) and Omalizumab (21.4%). The time on biologic when commencing HSA was 19 (IQR 21.8) months, with an annual review 12 (IQR 8.3) months later. Previously obtained improvements in asthma control, lung function, eosinophil suppression and oral corticosteroid use, were maintained in 53(95%) of the patients (Table 1). HSA was stopped in 3(5%) patients due to deterioration in asthma control. Conclusion(s): The vast majority of patients recieving HSA of biologics maintained previous improvements across asthma outcomes, thereby strongly supporting the use of HSA in the correctly identified patient, consequently optimising service capacity. Appropriate monitoring arrangements are still needed to promptly identify any deterioration. (Table Presented).

Patient's experience and satisfaction with self-administered subcutaneous depot medroxyprogesterone acetate use during the first year of COVID-19.

OBJECTIVES: Self-administered subcutaneous (SC) depot medroxyprogesterone acetate (DMPA) can improve contraception access by eliminating a health center visit for administration. For patients at our New York City health centers who were offered a switch to self-administered DMPA-SC at the onset of the coronavirus 2019 (COVID-19) pandemic, we sought to understand their experience of choosing to switch, of accessing and using the method, and their method satisfaction. STUDY DESIGN: Individual interview study of 22 patients using intramuscular DMPA prior to the start of the pandemic. All had a telehealth visit to discuss switching to self-administered DMPA-SC and received a DMPA-SC prescription during the first months of COVID-19. We used a grounded theory analysis approach. RESULTS: Respondents viewed switching to self-administered DMPA-SC as a decision they had to make if they wanted to continue DMPA. Most respondents experienced logistical challenges acquiring DMPA-SC from their pharmacy. Issues around convenience were important to respondents; however what respondents found convenient varied. Despite all this, respondents appreciated having the option of DMPA-SC and felt it to be overall empowering. CONCLUSIONS: This study exploring patients' experience with self-administered DMPA-SC during the initial year of the COVID-19 pandemic found that, notwithstanding initial hesitation about self-administered injections and logistical challenges getting the SC formulation, many found the experience of trying self-administered DMPA-SC to be empowering and appreciated having this option. Thus, self-administered DMPA-SC should be included in clinicians' routine contraception counseling and provision, insurance companies should cover DMPA-SC without requiring prior authorization, and pharmacies should consistently stock DMPA-SC. IMPLICATIONS: Self-administered DMPA-SC is an acceptable contraception option that provides an opportunity to maintain contraception access while eliminating need for an in-person visit. Thus, self-administered DMPA-SC should be included in clinicians' routine contraception counseling and provision, insurance companies need to cover this contraceptive without need for prior authorization, and pharmacies should consistently stock DMPA-SC.

RECENT TRENDS IN SELF-ADMINISTERED DRUG DELIVERY SYSTEMS WHAT DOES 2022 HAVE IN STORE FOR SELF-ADMINISTERED INJECTABLE DRUG DELIVERY?

Peter Hirst, Head of Commercial, Advanced Delivery Systems at Recipharm, discusses the fast-changing pharmaceutical market landscape and explores the latest trends driving innovation in self-administered injectable drug delivery. Some trends that are pushing growth in this area are directly linked to the COVID-19 pandemic, including the need to ease the healthcare burden. These effects will continue to be felt well into 2022, so now is the time for pharmaceutical companies to take action in order to overcome the challenges self-administration brings about, and ensure that their technology puts them in the best position to create opportunities and benefits in this space. © 2022 TeknoScienze. All rights reserved.

Home-based treatment of biologics for asthma: who, what, where, when and why.

INTRODUCTION: The advent of biologic therapies for severe asthma has profoundly changed the management of this pathology. The introduction of home administration is therefore an important innovation to optimize the patients' management, even if there are many aspects that need to be clarified and pointed out. AREAS COVERED: This review summarizes the path that led to the possibility of self-administration of biologics, and what the pandemic has changed in the management of these patients. EXPERT OPINION: The growing understanding of asthma phenotypes and endotypes is enabling the careful selection of patients suitable for biologics. In this context, the availability of reliable and simple self-injection devices is important in implementing self-administration. The transition to self-injection is also possible thanks to the high safety profile of biologics. With attention, most patients may potentially be suitable for self-administration. The transition process from hospital to home administration can therefore be carried out correctly by clinicians with adequate expertise in the field of severe asthma and biologic therapies, with the support of other health professionals, pharmacists, and general practitioners. Home administration is probably the best way to guarantee high adherence and high-level satisfaction of patients, even in the long term.

Fixed Drug Eruption Secondary to Fluconazole Confirmed by Self-Challenge

Introduction: Fixed drug eruption (FDE) can have a wide array of culprits, especially in patients who use multiple medications. We present a patient with Fixed Drug Eruption (FDE) secondary to fluconazole. Case Description: A 36-year-old female was evaluated for recurrent pruritic and tender violaceous to hyperpigmented patches on her face (Figure 1A), neck, upper extremities, buttocks, flank, and genitals. Patches would blister after 2-3 days. These lesions occurred every 2-3 months for 1 year with Non-Steroidal Anti-inflammatory Drugs (NSAIDs) or fluconazole, and after her second Pfizer COVID-19 vaccine with acetaminophen as premedication. Punch biopsy showed focal dyskeratosis, papillary dermal eosinophils and neutrophils (Figure 1B). She was diagnosed with FDE and instructed to avoid NSAIDs, Polyethylene Glycol (PEG), over-the-counter medications, and fluconazole. Patch testing was performed for fluconazole (pet 5%), ibuprofen (pet 5%), celecoxib (pet 10%), povidone (pet 2% and liquid), and croscarmellose (pet 10% and liquid). All patch tests were negative at 48 hours, 72 hours, 5 days, and 7 days readings. Prior to performing a provocation test, the patient self-administered fluconazole for vaginal itching and the FDE recurred within 2 minutes on the same locations. She tolerated celecoxib and COVID19-vaccine booster without adverse reactions. The patient was instructed to avoid all azoles and use alternative agents. Discussion(s): When multiple possible agents are suspected in FDE, patch testing followed by provocation tests may be considered. In this case, the diagnosis was confirmed by self-administration of fluconazole. Copyright © 2022

Efficacy of subcutaneous versus intravenous administration of desmopressin in patients with von Willebrand disease and hemophilia A in need of COVID-19 vaccination

Background: Subcutaneous desmopressin (DDAVP) can be more easily administered than intravenous DDAVP and may be an efficacious alternative for the currently unavailable intranasal DDAVP to treat mild bleedings or for minor invasive procedures in von Willebrand disease (VWD) and hemophilia A. Aim(s): To compare the one-hour response to subcutaneous and intravenous DDAVP in patients with VWD or hemophilia A. Method(s): Patients with hemophilia A (FVIII <=10 IU/dl) or VWD (VWF activity <=10 IU/dl) whose treatment plans include DDAVP and who were to receive a COVID-19 vaccination were eligible to participate. For COVID-19 vaccination, FVIII or VWF activity target levels of >10 IU/dl were pursued according to international guidelines (ISTH). DDAVP was administered subcutaneously 1.5 h before vaccination. FVIII (in hemophilia and VWD) and VWF activity levels (in VWD) were determined prior to (t = 0) and 1 h after DDAVP (t = 1). All patients had a positive historical routine challenge test with intravenous DDAVP. For each participant, absolute and relative changes of FVIII and VWF activity levels 1 h after subcutaneous and intravenous DDAVP (both 0.3 mug/kg) were compared. Result(s): Eleven patients were included: Six with hemophilia A, three with VWD type 2M and two with VWD type 2A. Both intravenous and subcutaneous DDAVP increased FVIII and VWF activity levels in all patients. In hemophilia patients, intravenous and subcutaneous DDAVP increased FVIII levels by an average of 3.8-fold and 3.4-fold respectively. Peak FVIII activity levels at t = 1 ranged from 25-62 IU/ dl and 29-51 IU/dl. In VWD patients, intravenous and subcutaneous DDAVP was associated with a 11.4-fold and 5.1-fold mean increase in VWF activity levels respectively. Corresponding peak VWF activity levels ranged from 18-100 IU/dl and 28-74 IU/dl. No bleeding after vaccination was reported. Conclusion(s): Subcutaneous DDAVP appears to be an effective alternative for intravenous DDAVP. Moreover, like intranasal DDAVP, subcutaneous DDAVP allows the possibility of self-administration at home.

Home denosumab self-administration: a service development project

AUTH Why you should read this article: • To learn about the experience of two trusts that set up a home denosumab self-administration service for patients during the coronavirus disease 2019 (COVID-19) pandemic • To recognise the need for a robust, comprehensive and consistent training process for patients to self-administer denosumab at home safely • To identify the benefits for patients and their families of a home denosumab self-administration service In October 2012 the National Institute for Health and Care Excellence approved the use of subcutaneous denosumab for the management of bone metastases from solid tumours. For patients receiving intravenous chemotherapy, denosumab can be administered in parallel with this, obviating the need for additional hospital visits. However, patients receiving oral chemotherapy or denosumab alone often must attend hospital solely for a subcutaneous injection of the latter. This article describes the experience of two NHS trusts in setting up a home self-administration service for denosumab during the coronavirus disease 2019 (COVID-19) pandemic. The service development project took place during 2020-2021. The article explores the barriers to and facilitators of this project and reports the results of a patient feedback survey which showed that all respondents wished to continue self-administration of denosumab at home.

Perceptions on Home-Administration of Biologics in the Context of Severe Asthma: An International Qualitative Study.

BACKGROUND: Biologics are an effective therapy for severe asthma. Home administration of biologics by patients is likely to facilitate their accessibility. Yet little is known about patients' and health care providers' (HCPs) perceptions regarding home administration of biologics. OBJECTIVE: The aim of this study is to create more insight into the perceptions and experiences of patients and HCPs regarding home administration of biologics in the context of the treatment of severe asthma. METHODS: A qualitative international study was performed in the Netherlands, United States, Australia, and United Kingdom. In each country, 2 focus groups were held with potential/recent and long-term users of biologics at home. Prior to the focus groups, patients were prompted with themes on online forums. For triangulation purposes, interviews were held with HCPs to discuss salient findings from forums and focus groups. Data were analyzed with qualitative content analysis. RESULTS: In total, 75 patients participated in the forums, of which 40 participated in the focus groups. Furthermore, 12 HCPs were interviewed. The following overarching themes were identified: living with severe asthma; practical aspects of using biologics; the role of HCPs regarding biologics; social support from family, friends, and others; effectiveness of biologics and other treatments; side effects of biologics. CONCLUSIONS: This study showed that, for those using biologics for severe asthma, the benefits of home administration of biologics usually outweigh inconvenience and side effects. Guided practice, accessible support contact, and monitoring including social support should be central in the transition from hospital to home administration of asthma biologics.

Prevalence and Determinants of Antibiotic Self-Administration Among Adult Antibiotic Users: A Cross-Sectional Study.

Introduction: Each year, antibiotics save hundreds of thousands of lives; nonetheless, antibiotic self-administration is a major concern all over the world. This study aimed to investigate the prevalence of antibiotic self-administration among two-month adult antibiotic users as well as the factors contributing to this prevalence. Method and Participants: This cross-sectional study was conducted among 295 Bangladeshi adults between May 22nd and June 15th, 2021, during the COVID-19 pandemic. Descriptive statistics included frequency distribution, while inferential statistics included the Pearson chi-square test. For data analysis, the statistical software STATA-16 was used. Results: In this study, the prevalence of antibiotic self-administration was 17.97%. Antibiotic self-administration was found to be significantly more prevalent among those who were unable to take antibiotic on time, incomplete doses, did not know over prescriptions may cause antibiotic resistance, and could not correctly recognize amoxicillin and azithromycin are antibiotics. Conclusion: Due to the increased rate of antibiotic self-administration among adults in Bangladesh, the responsible authority should give more attention towards the factors responsible for antibiotic self-administration and revise their current policy to ensure the safe and effective use of antibiotics.

Altered Accumbal Dopamine Terminal Dynamics Following Chronic Heroin Self-Administration.

Administration of heroin results in the engagement of multiple brain regions and the rewarding and addictive effects are mediated, at least partially, through activation of the mesolimbic dopamine system. However, less is known about dopamine system function following chronic exposure to heroin. Withdrawal from chronic heroin exposure is likely to drive a state of low dopamine in the nucleus accumbens (NAc), as previously observed during withdrawal from other drug classes. Thus, we aimed to investigate alterations in NAc dopamine terminal function following chronic heroin self-administration to identify a mechanism for dopaminergic adaptations. Adult male Long Evans rats were trained to self-administer heroin (0.05 mg/kg/inf, IV) and then placed on a long access (FR1, 6-h, unlimited inf, 0.05 mg/kg/inf) protocol to induce escalation of intake. Following heroin self-administration, rats had decreased basal extracellular levels of dopamine and blunted dopamine response following a heroin challenge (0.1 mg/kg/inf, IV) in the NAc compared to saline controls. FSCV revealed that heroin-exposed rats exhibited reduced stimulated dopamine release during tonic-like, single-pulse stimulations, but increased phasic-like dopamine release during multi-pulse stimulation trains (5 pulses, 5-100 Hz) in addition to an altered dynamic range of release stimulation intensities when compared to controls. Further, we found that presynaptic D3 autoreceptor and kappa-opioid receptor agonist responsivity were increased following heroin self-administration. These results reveal a marked low dopamine state following heroin exposure and suggest the combination of altered dopamine release dynamics may contribute to increased heroin seeking.

SUPPORTING PATIENTS ON THE ROAD TO SELF-CARE

In this article, Michael Earl, Director, Pharmaceutical Services, at Owen Mumford, discusses the importance of transitioning current healthcare models to embrace patient self-management and how advanced drug delivery device technologies, such as connectivity, can ease this burden on overstretched healthcare services.

Impact of the Global Pandemic on Accrual for a Non-Covid-19 ICU Clinical Trial

RATIONALE: Enrollment and retention of participants for any research study is challenging. The unpredictable nature of the ICU environment coupled with tenuous physiological status of patients can significantly thwart clinical trial accrual goals. The COVID-19 pandemic has pushed ICU census numbers to unprecedented levels with severely ill patients experiencing lengthy hospitalizations, delaying turn-over of beds. Anecdotal reports suggest challenges in achieving trial recruitment goals. The aims of this study were to describe the impact of the pandemic on a non-COVID-19 ICU clinical trial's screening and accrual of patients receiving mechanical ventilatory support. METHODS: A descriptive, retrospective design was used to address the study aims. Screening and accrual data were obtained from a Midwestern academic medical center in North America's parent clinical trial (R01HL130881). The primary aims of the efficacy trial are to test if patient selfadministration of dexmedetomidine (n = 190) reduces anxiety, delirium, ventilator days and ICU stay. A 3-step screening process prior to informed consent consists of (1) electronic health record (EHR) automated ICU census reports of mechanically ventilated patients, (2) in-depth review of the EHR for inclusion criteria, then (3) bedside assessment of grip strength to use a push-button medication delivery device and ability to follow commands. Descriptive statistics and Chi-square were used to compare screening and accrual data from a pre-pandemic timeframe (8/27/2018- 3/15/2020) to a pandemic timeframe (3/16/2020-12/31/2021). RESULTS: Of 91 eligible patients, 49 were accrued (53.8%) during the pre-pandemic timeframe. Patients were not accrued due to patient/LAR declination (78%) or primary medical team declination (22%). The three most frequent reasons for ineligibility were unarousable (25%), hypotension (11%) and not following commands (9%). While the pandemic timeframe had 30 fewer eligible patients, 40 of 61 (67%) were accrued. Patients were not accrued due to patient/LAR declination (87%) or medical team declination (13%), similar to pre-pandemic timeframe (p = 0.7). Pandemic timeframe had significantly more unarousable patients (32%, p < 0.0001) with fewer patients hypotensive (7%, p < 0.0001) or not following commands (7%, p = 0.01). Once COVID-19 infection was resolved, lengthy ventilator days, higher sedation levels, and prolonged immobility contributed to extremely weak grip strength, precluding trial eligibility. CONCLUSIONS: These retrospective data confirm this trial's enrollment was hampered by the COVID-19 pandemic due to fewer eligible, unarousable patients. Declinations from patients/LARs were similar during both timeframes. Inability to meet accrual milestones risks continued.

Usability, acceptability, and feasibility of a High-Density Microarray Patch (HD-MAP) applicator as a delivery method for vaccination in clinical settings.

BACKGROUND: High-density microarray patch (HD-MAP) vaccines may increase vaccine acceptance and use. We aimed to ascertain whether professional immunizers (PIs) and other healthcare workers (HCWs) in Australia, a High-Income Country (HIC), found the HD-MAP applicator usable and acceptable for vaccine delivery. METHODS: This feasibility study recruited PIs and HCWs to administer/receive simulated HD-MAP administration, including via self-administration. We assessed usability against essential and desirable criteria. Participants completed a survey, rating their agreement to statements about HD-MAP administration. A subset also participated in an interview or focus group. Survey data were analyzed using descriptive statistics, and interviews were transcribed and subject to thematic analysis. RESULTS: We recruited 61 participants: 23 PIs and 38 HCWs. Findings indicated high usability and acceptability of HD-MAP use across both groups by a healthcare professional or trained user and for self-administration with safety measures in place. Most administrations met essential criteria, but PIs, on average, applied the HD-MAP for slightly less time than the required 10-seconds, which the HCWs achieved. PIs perceived safety concerns about home administration but found layperson self-administration acceptable in an emergency, pandemic, and rural or remote settings. CONCLUSIONS: Participants found HD-MAP administration usable and acceptable. Usability and acceptability are likely to be improved through end-user education and training.

Professional immunizers and healthcare workers found high-density microarray patch devices highly usable and acceptable to administer vaccines.HD-MAPs may have advantages over intramuscular injections in clinical settings and in pandemics.Vaccination with HD-MAP may improve acceptance for those with needle-related anxiety.

Reliability, Satisfaction and Effectiveness of Benralizumab Home Self-Administration in Patients with Severe Eosinophilic Asthma in Real-World Practice: The Auto-Benra Study.

Introduction: The increase in drugs available for severe uncontrolled asthma and the lifestyle of these patients make it necessary to implement self-administration programs of these therapies at home. Benralizumab, a monoclonal antibody targeting IL5R, was authorized in Spain for poorly controlled severe eosinophilic asthma. The possibility of administration at home was approved in March 2020 in Spain. The aim of the Auto-Benra study was to evaluate the usability and satisfaction of the benralizumab prefilled syringe and autoinjector and assessing the effectivity of these devices in uncontrolled severe eosinophilic asthma (SEA) in home-self administration. Methods: This is a retrospective, observational multicenter study uncontrolled SEA patients treated with benralizumab at least with 3 doses self-administered at home before April 30, 2021. Reliability and satisfaction with benralizumab at home were evaluated with subcutaneous administration assessment questionnaire (SQAAQ) and visual analogic scales (VAS). Effectiveness was evaluated in all patients with asthma control test (ACT), Mini Asthma Quality of Life Questionnaire (MiniAQLQ), annual exacerbation rate, oral corticosteroid treatment (OCS) and asthma-related hospitalizations and emergency visits. Results: Fifty-four patients across 9 hospitals in Spain were included. The mean SQAAQ score was 6.89 (±0.16) points. Patients and their caregivers and doctors report excellent satisfaction by VAS, with no differences between benralizumab devices used (prefilled syringe and autoinjector). Severe exacerbation rate decreased by 65% (p = 0.0007) after benralizumab treatment. ACT score improved on average 6.27 ± 5.35 points (p < 0.0001) and the mean MiniAQLQ increased up to 1.58 ± 1.47 points (p < 0.0001). Twenty-four patients were OCS-dependent and at the end of study 14 patients get complete OCS withdrawal. Conclusion: AUTO-BENRA study supports the use of benralizumab at home given the excellent results of satisfaction and usability by patients and their caregivers.

Telemedicine in Patients with Fragility Fractures in the COVID-19 Era

Introduction: The covid19 pandemic has forced the health system to restructure to prevent contagion of our patients. In this context, the members of the Orthogeriatric Group of the Catalan Society of Geriatrics and Gerontology (SCGiG) created a document that collected all the considerations to take into account during the pandemic, based on the current guides and scientific societies, in order to perform a correct follow-up, enhance adherence and prevent future falls. Methods: A bibliographic review was performed, defining the key points in the care of the fractured patient through telemedicine (document is available at http://scgig.cat/docs/gt-orto-covid.pdf). Results: During hospital admission, antiosteoporotic treatment should be started, evaluating indications with the patient and family, to ensure adherence. Diet intake of calcium and vitamin D will be assessed. Discharge report includes evaluation of treatment and monitoring plan, to be useful for liaison nurse, rehabilitator and general practitioner. Six-monthly follow up is recommended for patients with comorbidities, polypharmacy, confusion, fall-risk, or parenteral anti-osteoporotic treatment. With denosumab or teriparatide, annual laboratory tests are recommended, with GFR <20, every six months, at home if possible. Bisphosphonates can be followed by the GP. Zoledronate is not recommended due to delayed administration after surgery, and possibility of transient flu-like simptoms. In the telematic follow-up visit, in patients undergoing zoledronic acid treatment, the new dose can be delayed for 6-12 months, without risk. Consider sequential treatment. Denosumab treatment cannot be delayed, so the patient and family will be trained in self-administration. Support materials from laboratories will be useful to patient and caregivers. Conclusion: Telemedicine is a good strategy for a follow-up, to avoid hospital contact, and starts on hospital admission. Patient and caregivers need access to new technologies and able to understand medical instructions.

An Innovative Review Study on Using Pulmonary Vaccination in COVID 19 Pandemic

The current state of pulmonary vaccine delivery will be discussed in this review. The prospects for lung immunization using dry powder generation technologies and specialized medicinal formulations are discussed. In terms of vaccine durability and antigenicity, dry powder vaccine generation technologies may be advantageous. The non-invasive, reasonably safe, and low-cost nature of pulmonary delivery could help the public health vaccination significantly. The vaccines, which are all given intramuscularly, produce systemic antibodies in the blood but not antibodies in the pulmonary mucosal lining. Inhalation vaccines provide a number of potential benefits over injectable vaccines, including ease of delivery, and even self-administration. To create a dry powder inhalation formulation that is breathable and mediates robust transfection in the lung, a safe and effective mRNA delivery vector as well as a suitable particle engineering approach is needed.

Self-injection of denosumab in clinical practice in the french pilote study

Objective: Describe characteristics of patients who self-inject denosumab and patterns of self-injection in France. Methods: PILOTE was a prospective observational study that evaluated persistence to denosumab over 24 months in France in postmenopausal women. Clinical information obtained through routine practice was recorded onto an eCRF, including the individual who injected subcutaneous denosumab (physician, nurse, patient, other). We conducted an ad hoc analysis of the patients in the study who self-injected denosumab. Results: In total, 478 patients were enrolled between June 2105 and February 2016. 27 patients self-injected denosumab at least once, with these patients distributed across multiple sites. Those who self-injected appeared slightly younger with longer duration of osteoporosis, and a higher proportion had a prior fracture and previous glucocorticoid and teriparatide treatment than the overall population (Table). Self-injected patients were also more likely to be living at home with family, have a University education, and be seen by a rheumatologist than a GP. Twelve patients self-injected from the beginning of the study, 15 self-injected after receiving injection from an HCP and 8 switched back to HCP injections after self-injection. Eleven of the 12 patients who self-injected from the beginning were persistent at 24 months. Six ADRs occurred in three self-injecting patients: one vertebral fracture, bone pain, muscle fatigue, myalgia, asthenia, pyelonephritis. Conclusion: Although numbers were small, self- administration of denosumab appeared feasible for women with postmenopausal osteoporosis and may be a valuable option, particularly in the context of the COVID-19 pandemic when office visits are restricted. (Table Presented).