Exploring the views of care home staff on the use of antipsychotics for people with dementia amid the COVID-19 pandemic: A qualitative study

Introduction: There was an increase in antipsychotic prescribing for people with dementia during the COVID-19 pandemic (1). To explain this increase, the current study was conducted to explore the views of staff working in care homes for the elderly during the pandemic on the use of antipsychotics for residents with Behavioural and Psychological Symptoms of Dementia (BPSD). Aim(s): The aim was to explore the use of antipsychotics for people with BPSD during the COVID-19 pandemic by interviewing staff in care homes about their experiences during that time. Method(s): Semi-structured interviews were conducted online with staff working in ten UK elderly care settings using convenience sampling. Participants mainly onsite care home staff were recruited through online networks, for example, Twitter, and support groups such as CHAIN and NIHR clinical research network. Interviews were conducted between May 2021-March 2022, were audio recorded, transcribed verbatim, and analysed inductively using thematic analysis in NVivo version 12. Result(s): Ten interviews were completed with managers (n=2), care staff (n=6) and nurses (n=2) in nursing homes (n=7) and residential homes (n=3) (all were female). The first theme 'Challenges experienced in care provision' entails challenges experienced in the care environment;residents were confined to their rooms, activities were suspended, staff were absent and stressed, and family visits were barred. The reduced human contact affected residents' sense of self, mental and physical wellbeing, and in turn, their behaviours. The second theme 'Prescribing process' refers to doctors prescribing medicines in response to staff raising concerns. The third theme 'Attitude toward antipsychotics' denotes participants' positive and negative beliefs about antipsychotics. The positive beliefs included antipsychotics being the right choice and beneficial, an increased need and continued use of antipsychotics, use of a combination of medications and weighing the risks and benefits of antipsychotics. The negative beliefs included reports of adverse effects and short-term benefits of antipsychotics, antipsychotics not always beneficial, benefits in deprescribing, dislike for antipsychotics and belief antipsychotics are the last resort. Some expressed the need for antipsychotics had not increased but been driven by health professionals involved. The fourth theme 'Other psychotropic medication' alluded to other commonly used psychotropic medications and associated risks and benefits. The fifth theme 'Measures implemented within care settings' represented strategies implemented to avert the initiation or bolster antipsychotic deprescribing such as non-pharmacological approaches, nurses' assessment of residents before requesting antipsychotics, multidisciplinary consultation, and medication review. Conclusion(s): This is the first study that reports care home staff views on antipsychotic use for residents with dementia during the pandemic. The limitations include that only views of female respondents were obtained and the limited sample size. Care homes faced enormous challenges in the provision of care services to residents with dementia during the pandemic. The multitude of difficulties experienced in care homes due to lack of preparedness may have influenced staff to have positive views of antipsychotics and their use as an option during the pandemic. It's important to acknowledge and address these difficulties for example through education and training interventions to help with future preparedness.

Co-designing an intervention to support safe medicines self-management for older people living with frailty and polypharmacy

Introduction: Older people face numerous challenges and safety risks when managing multiple medicines. They are required to cope with complex and changing regimens and co-ordinate input from multiple healthcare professionals. If not well managed, medicines can cause harm, and older people are more susceptible to errors. Some older people can devise and implement strategies to manage their medicines, e.g. creating checklists, ensuring timely supplies, solving problems, and seeking help (1). However, no interventions address the multiple tasks polypharmacy patients must perform to safely manage their regimens. Aim(s): To develop an intervention to support medicines self-management for older people living with frailty and polypharmacy using experience-based co-design (EBCD) (2). Method(s): Following video or audio-recorded qualitative interviews with 32 older people taking 5 or more medicines, a 'trigger film' of patients' medicines management experiences was produced and used during EBCD to facilitate priority setting. Separate meetings were held (1) with 16 staff (2 GPs, 4 GP practice administrators, 4 GP practice pharmacists, 1 practice lead, 2 senior nurses, 2 pharmacy technicians, 1 community pharmacist) and (2) with 13 patients and 2 family members, followed by a joint meeting with 8 older people and 9 staff where a shared set of three priorities was agreed. Two subsequent co-design workshops with 6 patients, 2 family members and 7 staff developed three candidate interventions. Workshop 1 explored key themes from the trigger film to develop solutions. Workshop 2 reviewed solutions and further developed design ideas. Intervention components were merged and those addressing patient safety challenges were retained to form the prototype intervention. Ethical approval was obtained for the interviews included in the trigger film, but not required for EBCD. EBCD meetings and workshops were conducted as quality improvement: people involved were collaborators, personal information was not captured, discussions were not recorded or analysed. Result(s): Co-design priorities were to support patients in: day-to-day practical medicines management;understanding the wider medicines management system;communication with healthcare teams. The three solutions were: a quick-start guide to managing multiple medicines including talking about medicines and managing new routines;tips and tricks to support day-to-day management, including planning and adherence tools;a tool supporting preparation for medication reviews and asking questions about medicines. After merging intervention components and identifying those addressing medicinesself- management patient safety challenges, five areas were retained for the prototype intervention: checking what you get;keeping on top of supplies;monitoring how you take your medicines;times when problems are more likely;and how do I know if I need help? Discussion/Conclusion: Through EBCD patients and staff worked together to improve people's experiences of managing medicines and to enhance safety. The prototype intervention addresses five areas where older people with complex medicines regimens require support. The intervention requires feasibility testing and subsequent robust evaluation. Strengths and limitations: * A variety of staff roles joined the co-design, offering multiple different perspectives on medicines management * EBCD meetings and workshops were run online to avoid Covid infections. This may have excluded older people with no access to internet.

Patient perspectives of safe and routine deprescribing for older people living with polypharmacy: an interview study

Introduction: Stopping medicines where harms outweigh benefits (deprescribing) (1) can reduce adverse events from inappropriate polypharmacy. Deprescribing should be undertaken in a patient-centred way with shared decision-making. However, there is a lack of evidence about the patient perspective on how deprescribing should be safely and routinely implemented in UK primary care. Such evidence is needed to enhance the implementation of deprescribing in primary care. Aim(s): * To identify optimal methods of introducing and actioning deprescribing from the patient's perspective * To understand the nature of support patients require during deprescribing * To identify patient views on the involvement of different healthcare professionals in deprescribing. Method(s): UK patients aged >=65 years taking >=5 medicines and living in their own homes were recruited through social media, service user groups and NIHR People in Research. An interview guide was developed using deprescribing literature, patient and public involvement input, and informed by the theoretical implementation framework Normalisation Process Theory (2). Interviews were conducted online (Microsoft Teams) or via telephone, audio recorded and transcribed verbatim. Data were analysed using the Framework method. Result(s): Twenty patients, diverse in age and gender, were recruited and three main themes developed: 1. 'Why deprescribe now?' focused on the importance of communicating the deprescribing rationale;2. 'Monitoring and follow-up' in which safety netting around deprescribing and patients' motivations to self-monitor after deprescribing interventions were highlighted;3. 'Roles and relationships' focused on patient views of different healthcare professionals involved in deprescribing and the interpersonal skills needed to develop therapeutic relationships. Conclusion(s): Optimal methods of introducing deprescribing from the patient's perspective included communication of a convincing and well-communicated rationale for stopping medicines. Patients required support from a range of healthcare professionals with whom they had an existing therapeutic relationship. Whilst patients were motivated to self-monitor any unwanted/unexpected effects post-deprescribing, this was under the condition that timely support would be available when needed. These findings provide a deeper understanding of patients' needs for the implementation of safe and routine deprescribing in primary care, and these should be considered when designing medication review and deprescribing services. A strength of this study was the overall diversity in age and gender of the patients interviewed. However, although multiple recruitment pathways were utilised, due to the COVID-19 pandemic, recruitment was mainly online which will have excluded patients who did not have access to the internet.

Medicines optimisation for residents with dementia during the COVID-19 pandemic: a qualitative study of the views and experiences of care home managers

Introduction: The COVID-19 pandemic has disproportionately affected people with dementia, especially those in care homes (1). The pandemic may have exacerbated existing medication challenges that care home residents with dementia may experience, such as issues with adherence and administration. Aim(s): To explore the views experiences of care home managers in Northern Ireland (NI) about optimising medicines use and accessing primary healthcare services for residents with dementia during the COVID-19 pandemic and identify key lessons for supporting care home staff with medicines optimisation for residents with dementia both now and during future health crises. Method(s): Care home managers were recruited using several approaches which utilised purposive and snowball sampling. Participant sampling and recruitment commenced in January 2022 and finished in July 2022. The interview topic guide was developed based on published literature, current COVID-19 guidelines for care homes, and following discussion within the research team;it was piloted with two nurses with experience of working in care homes. Semi-structured interviews were conducted either using an online video-conferencing platform or via the telephone after obtaining written informed consent from participants. All interviews were audio recorded, transcribed verbatim, and analysed using thematic analysis (2). Analysis of data is ongoing. Result(s): Fourteen interviews were conducted, lasting between 25 and 56 minutes. Findings to date have highlighted the challenges care homes have faced whilst caring for residents with dementia during the pandemic. Participants described changes to the way in which primary healthcare services were provided. In particular, provision of services from general practice (e.g. prescribing, consultations) were mostly conducted over the telephone and/or online and some participants reported that this had an impact on medication review: ''it's only the review of medication that has not been done during the pandemic'' [CHM-07]. Restrictions on visiting to care homes during the initial and middle phases of the pandemic affected aspects of medicines optimisation for residents with dementia and an already stretched care sector: There was a lot of problems prior to COVID. COVID just made those problems monumental'' [CHM-14]. Most participants perceived that community pharmacy services were not affected by the pandemic and medication supply continued: We haven't had an issue with community pharmacy to be honest with you'' [CHM-03]. Participants identified lessons for future health crises including the need for improved communication with general practitioners, the importance of a multidisciplinary team effort to optimise medicines for residents with dementia, along with input from residents' family members, and greater support for care homes. Conclusion(s): This study has highlighted the difficulties that care home managers have faced in accessing general practice services during the pandemic and the impact this has had on residents with dementia receiving medication review. Whilst these findings add to a limited evidence base, they may not be generalisable to other parts of the UK. Future work will focus on development of a questionnaire study with care home managers.

Some factors influencing in France the prescribers and public perception of the Drug marketing authorization decisions

The sacrosanct image that the prescriber and the public had of the Marketing Authorization (AMM) three or four decades ago has changed significantly in recent years, following the consideration – sometimes controversial – some of its shortcomings or weaknesses. The text of this article discusses some of the factors that may explain this change in mentality, which is harmful to patient safety. Among these factors, mention should be made of the quite understandable lag of certain MAs on the data acquired from science, a sometimes excessive and counterproductive formalism or even possible disagreements between the Agencies responsible for the registration of medicinal products. But it is especially necessary to retain certain fragile marketing authorizations, with a degraded image, prematurely granted on non-optimal levels of evidence with the aim of accelerating patients' access to new so-called "promising” drugs. Finally, the intervention of patients, now very important in the field, is a social phenomenon that should not be overlooked, either because they are wary of the drug and its evaluation or because they put pressure on the prescriber to obtain a prescription. off-label touted in social networks. The fact remains that MA remains the reference and benchmark to be respected for optimal, secure and responsible drug prescription. A positive point is that the pandemic due to COVID-19 will have enabled journalists to better master the notions of level of proof and balance between benefits and risks. At the same time, it will have enabled the public, for the most part, to understand what an MA is and to admit the need for it, despite the erosion of its confidence in scientific expertise and its suspicion towards to health institutions. If there is no reason to regret that more transparency and health democracy allow the citizen to appropriate the meaning and the determinants of MAID, there is reason, for evaluation specialists, to call for the maintenance of its rigor in the very interest of patients and for the health authorities to maintain it. © 2022 l'Académie nationale de médecine;L'image sacro-sainte que le prescripteur et le public se faisaient de l'Autorisation de mise sur le marché (AMM) il y a trois ou quatre décennies a notablement évolué depuis quelques années, suite à la prise en compte – parfois polémique – de certaines de ses insuffisances ou de ses faiblesses. Le texte de cet article évoque quelques-uns des facteurs pouvant expliquer cette évolution des mentalités, délétère pour la sécurité des patients. Parmi ces facteurs, on mentionnera le retard bien compréhensible de certaines AMM sur les données acquises de la science, un formalisme parfois excessif et contre-productif ou encore de possibles discordances d'avis entre Agences responsables de l'enregistrement des médicaments. Mais il faut surtout retenir certaines AMM fragiles, d'image dégradée, prématurément octroyées sur des niveaux de preuve non optimaux dans le but d'accélérer l'accès des malades aux nouveaux médicaments dits « prometteurs ». Enfin, l'intervention des patients, désormais très importante dans le domaine, est un phénomène de société à ne pas méconnaître, soit qu'ils se méfient du médicament et de son évaluation ou qu'ils fassent pression sur le prescripteur pour obtenir une prescription hors AMM vantée dans les réseaux sociaux. Il n'en demeure pas moins que l'AMM reste la référence et le repère à respecter pour une prescription médicamenteuse optimale, sécurisée et responsable. Un point positif est que la pandémie due au COVID-19 aura permis aux journalistes de mieux maîtriser les notions de niveau de preuve et de balance bénéfices/risques. Par la même occasion, elle aura permis au public, dans sa très grande majorité, de comprendre ce qu'est une AMM et d'en admettre la nécessité, malgré l'érosion de sa confiance dans l'expertise scientifique et sa suspicion vis-à-vis des institutions de santé. S'il n'y a pas lieu de regretter que davantage de trans arence et de démocratie sanitaire permettent au citoyen de s'approprier la signification et les déterminants de l'AMM, il y a lieu, pour les spécialistes de l'évaluation, d'appeler au maintien de sa rigueur dans l'intérêt même des patients et pour les autorités de santé de la maintenir. © 2022 l'Académie nationale de médecine

EvaPharMed - Development and evaluation of an interprofessional education project for pharmacy and medical students: A pilot study

Introduction: Interprofessional education projects with pharmacy and medical students (PS and MS) are rare in Germany (Institut fuer Medizinische und Pharmazeutische Pruefungsfragen, 2019). However, for a future trustful collaboration personal contacts and mutual understanding are vital (Weisenborn et al., 2019). Care by an interprofessional team is beneficial for patients. According to the fifth Action Plan 2021 - 2024 to improve medication safety of the Federal Ministry of Health (2021), interprofessional collaboration is an important key element. Objective(s): The authors developed and implemented an interprofessional education project for PS and MS. The pilot study was conducted to understand the students' perceptions and to evaluate whether students were satisfied with their learning progress and would recommend this project. Method(s): The project, developed by an interprofessional team, consisted of three parts: (1) an interprofessional online seminar, (2) practical training at the Medication Management Center (MMC) and (3) a one-day internship in a general practitioner's (GP's) office. In all three parts, PS and MS performed patient-oriented casework and medication reviews together. The project was evaluated using anonymous pre- and post-questionnaires, containing the German version of the Student Perceptions of Physician-Pharmacist Interprofessional Clinical Education instrument (SPICE-2D) and open-ended questions to further evaluate the students' perceptions (Pudritz et al., 2020). The post-questionnaire asked for feedback as well as a recommendation of this project for other students, using a five-point Likert scale. Furthermore, the students' satisfaction with their learning progress was assessed. Result(s): Due to the SARS-CoV-2 pandemic, only the seminar (part 1) was performed in each term. The other parts of the project were implemented progressively. The third execution in the winter term 2021/22 was eventually able to contain all three parts. Through all executions, 105 students (46 PS, 59 MS) attended the interprofessional seminar, 64 (29 PS, 35 MS) the practical training at the MMC and nine joined the internship in a GP's office. For the seminar, 41 of 53 participants were satisfied with their learning progress and 64 of 67 students would recommend it to others. Regarding the practical training at the MMC, 37 of 46 students were satisfied with their learning progress and 45 of 47 would recommend it to others. Finally, the internship in a GP's office was mostly rated positive. Conclusion(s): Despite the pandemic, the interprofessional education project was successfully implemented. The insights gained from the evaluation will be used to adapt the project and its evaluation, eventually. Moreover, the development of further interprofessional education projects will benefit from the gained understanding. The focus of the evaluation of the main study will shift to the students' perceptions towards patient-oriented casework and medication reviews. In addition to the questionnaires, guided individual interviews will be used.

Rivaroxaban treatment failure during COVID-19 infection

Background: The Coronavirus Disease 2019 (COVID-19) has been shown to Increase incidence of venous thromboembolism (VTE). We describe a novel case of rivaroxaban treatment failure in a patient with COVID-19 infection who previously demonstrated efficacious treatment of prior pulmonary embolism (PE) with rivaroxaban Case presentation: A 75-year-old male patient originally presented for syncope and was found to have acute submissive PE on Computed tomography angiogram of his (CTA) chest. He was placed on heparin initially and he remained hemodynamically stable during his admission and was discharged home on rivaroxaban at standard induction dose. He presented again for shortness of breath 3 months later. CTA chest was repeated and demonstrated resolution of his prior PE. He was found to be positive for COVID-19 and admitted for further management, rivaroxaban was continued during his admission. Repeat CTA of his chest 2 weeks later demonstrated moderate right and small left PE without right heart strain. Vascular Medicine was consulted at that time. The patient reported taking his rivaroxaban as directed throughout the recommended course. He reported taking rivaroxaban with food. He said his son helped him with his medications and it was unlikely he missed any doses. He was able to get his medications from the Veterans Health Administration (VA) and had no issues with access to medications. Medication review revealed no drug interactions . that would decrease efficacy of rivaroxaban. The patient's weight of 116 kg was within the acceptable range for rivaroxaban use. Conclusion(s): This case is unique in that timing of CTA scans demonstrated complete resolution of patient's initial PE while taking rivaroxaban followed by new development of PE after COVID-19 infection despite continuation of rivaroxaban therapy.

Medication Use Evaluation of Ketamine for Sedation and Analgesia in Mechanically Ventilated Patients

INTRODUCTION: Ketamine, an NMDA receptor antagonist and mu/kappa opioid agonist, may be used for its anesthetic and analgesic properties as an alternative for sedation and analgesia in mechanically ventilated patients. Currently, there is limited literature evaluating the utilization of ketamine in critically ill patients. This study compared the efficacy and safety of ketamine as an adjunctive agent for sedation and analgesia compared to a non-ketamine cohort. METHOD(S): This was a multi-center, retrospective analysis of patients receiving ketamine as an adjunctive agent for sedation and analgesia compared to standard of care. Mechanically ventilated adult patients who received at least two continuous infusion sedative or analgesic agents from May 2020 to May 2021 were included. Patients receiving ketamine infusion as an adjunctive agent for at least six hours were included in the comparator group. The primary outcome evaluated was 28-day ventilator-free days. Secondary outcomes included impact on sedation and analgesic requirements, incidence of tachyarrhythmias, and increased secretions. RESULT(S): A total of 107 patients met criteria for inclusion, of which 54 received ketamine and 53 received nonketamine-based sedation. A COVID-19 diagnosis was present in 40 patients (74%) in the ketamine group and 14 (26%) in the non-ketamine group (p< 0.001). Ketamine was used less often in patients with history of head trauma (3 [5%] vs. 11 [21%];p=0.02), cirrhosis (0 [0%] vs. 7 [13%];p=0.006), and elevated intracranial pressure (0 [0%] vs. 5 [9%];p=0.03). Patients receiving ketamine had significantly fewer 28-day ventilator-free days (median 0 [0, 11] vs. 8 [0, 11] days;p=0.047). Patients receiving ketamine utilized greater median daily fentanyl doses (112 [65, 146] mcg/ kg vs. 30 [15, 59] mcg/kg;p< 0.001) and midazolam doses (70 [0, 171] mg vs. 0 [0, 59] mg;p< 0.001), but used no difference in propofol doses (19296 [0, 40387] mcg/kg vs. 24761 [12702, 41682] mcg/kg;p=0.1). There was no difference found in other outcomes evaluated. CONCLUSION(S): Addition of ketamine for sedation was chosen in select patient populations such as patients with COVID-19. Patients receiving ketamine had fewer 28-day ventilator-free days, potentially indicative of their presenting problem.

An International, Multicenter Evaluation of Pharmacist Medication Management in Icu Recovery Centers

INTRODUCTION: Post Intensive Care Syndrome (PICS) is a new or worsening impairment in physical, cognitive, or mental health following critical illness. Similar to PICS, survivors of critical illness due to COVID-19 may develop Post Acute Sequelae of SARS-CoV-2 Infection (PASC) or Long COVID. ICU recovery centers (ICU-RC) are suggested as an interprofessional approach to treat patients with PICS or PASC. Currently, over 40 different ICU-RC worldwide report having a clinical pharmacist. The purpose of this study was to describe the role of pharmacists in identifying and treating medication-related problems in survivors of critical illness. METHOD(S): This prospective, observational study was conducted in 12 ICU-RC between September 2019 and July 2021. A full medication review comprising of medication reconciliation, a patient interview, and counseling session was conducted by a clinical pharmacist on patients seen at the ICU-RC. Baseline demographic and hospital course data were obtained from the electronic health record and at the ICU-RC appointment. Data are reported using descriptive statistics. RESULT(S): A total of 507 patients were referred to an ICU-RC, of which 474 attended and 472 had a full medication review performed by a pharmacist. 237 (47%) of referred patients had a diagnosis of COVID-19. Pharmacy interventions were made in 397 (84%) patients. The median number of pharmacy interventions per patient was 2 (IQR 1,3). Medications were stopped and started in 124 (26%) and 91 (19%) patients, respectively. There was no difference in median total number of medications prescribed at the start and end of the patient visit (10, IQR = 5, 15). The number of patients that had a dose decreased and a dose increased was 51 (11%) and 43 (9%) patients, respectively. Adverse drug event (ADE) preventive measures were implemented in 115 (24%) patients and ADEs were identified in 69 (15%) patients. Drug interactions were identified in 30 (6%) patients. CONCLUSION(S): Pharmacists play an integral role in ICURC resulting in identification, prevention, and treatment of numerous medication-related problems. This paper should serve as a call to action on the importance of including a pharmacist on the interprofessional team in ICU-RC.

À propos des prescriptions hors Autorisation de mise sur le marché (AMM) : réflexions sur l'évolution de l'image de l'AMM chez le prescripteur et dans le public en France

Résumé L'image sacro-sainte que le prescripteur et le public se faisaient de l'Autorisation de mise sur le marché (AMM) il y a trois ou quatre décennies a notablement évolué depuis quelques années, suite à la prise en compte – parfois polémique – de certaines de ses insuffisances ou de ses faiblesses. Le texte de cet article évoque quelques-uns des facteurs pouvant expliquer cette évolution des mentalités, délétère pour la sécurité des patients. Parmi ces facteurs, on mentionnera le retard bien compréhensible de certaines AMM sur les données acquises de la science, un formalisme parfois excessif et contre-productif ou encore de possibles discordances d'avis entre Agences responsables de l'enregistrement des médicaments. Mais il faut surtout retenir certaines AMM fragiles, d'image dégradée, prématurément octroyées sur des niveaux de preuve non optimaux dans le but d'accélérer l'accès des malades aux nouveaux médicaments dits « prometteurs ». Enfin, l'intervention des patients, désormais très importante dans le domaine, est un phénomène de société à ne pas méconnaître, soit qu'ils se méfient du médicament et de son évaluation ou qu'ils fassent pression sur le prescripteur pour obtenir une prescription hors AMM vantée dans les réseaux sociaux. Il n'en demeure pas moins que l'AMM reste la référence et le repère à respecter pour une prescription médicamenteuse optimale, sécurisée et responsable. Un point positif est que la pandémie due au COVID-19 aura permis aux journalistes de mieux maîtriser les notions de niveau de preuve et de balance bénéfices/risques. Par la même occasion, elle aura permis au public, dans sa très grande majorité, de comprendre ce qu'est une AMM et d'en admettre la nécessité, malgré l'érosion de sa confiance dans l'expertise scientifique et sa suspicion vis-à-vis des institutions de santé. S'il n'y a pas lieu de regretter que davantage de transparence et de démocratie sanitaire permettent au citoyen de s'approprier la signification et les déterminants de l'AMM, il y a lieu, pour les spécialistes de l'évaluation, d'appeler au maintien de sa rigueur dans l'intérêt même des patients et pour les autorités de santé de la maintenir. Summary The sacrosanct image that prescribers and the public had of Drug Marketing Authorization (AMM) three or four decades ago has changed significantly over the past few years, following the recognition, – sometimes controversial – of some of its shortcomings or weaknesses. The text of this article discusses some of the factors that may explain this change in mentality, which is harmful to patient safety. Among these factors, we can mention the understandable delay of some AMMs on the data acquired from science, a sometimes excessive and counterproductive formalism, or even possible disagreements between the Agencies responsible for the registration of medicinal products. But above all, it is necessary to retain that some AMMs are fragile, with a degraded image, prematurely granted on sub-optimal levels of evidence with the aim of accelerating patients' access to new, so-called "promising” drugs. Finally, the intervention of patients, now very important in this field, is a social phenomenon that should not be overlooked, either because they are wary of the drug and its evaluation or because they put pressure on the prescriber to obtain an off-label prescription touted in social networks. The fact remains that the AMM remains the reference and the benchmark to be respected for an optimal, secure and responsible drug prescription. A positive point is that the pandemic due to COVID-19 has enabled journalists to better master the notions of level of proof and benefit/risk balance. At the same time, it will have enabled the vast majority of the public to understand what AMM is and to accept, for the most part, the need for it, despite the erosion of their confidence in scientific expertise and their suspicion towards the health institutions. If there is no reason to regret that more transparenc and health democracy allow the citizen to appropriate the meaning and the determinants of AMM, there is reason, for the evaluation specialists to call for maintaining its rigor in the very interest of patients and for health authorities to maintain it.

Regulatory reliance pathways during health emergencies: enabling timely authorizations for COVID-19 vaccines in Latin America.

Objectives: To map the timing and nature of regulatory reliance pathways used to authorize COVID-19 vaccines in Latin America. Methods: An observational study was conducted assessing the characteristics of all COVID-19 vaccine authorizations in Latin America. For every authorization it was determined whether reliance was used in the authorization process. Subgroups of reference national regulatory authorities (NRAs) and non-reference NRAs were compared. Results: 56 authorizations of 10 different COVID-19 vaccines were identified in 18 countries, of which 25 (44.6%) used reliance and 12 (21.4%) did not. For the remaining 19 (33.0%) it was not possible to determine whether reliance was used. Reference agencies used reliance less often (40% of authorizations with a known pathway) compared to non-reference agencies (100%). The median review time was just 15 days and does not meaningfully differ between reliance and non-reliance authorizations. Conclusions: This study demonstrated that for these vaccines, despite reliance pathways being associated with numerous rapid authorizations, independent authorization review times were not considerably longer than reliance reviews; reliance pathways were not a prerequisite for rapid authorization. Nevertheless, reliance pathways provided rapid authorizations in response to the COVID-19 emergency.

2022 ACCP Virtual Poster Symposium

The proceedings contain 127 papers. The topics discussed include: utility, safety, and necessity of as needed electrolyte replacement orders: a multi-center medication use evaluation;perceptions of inpatient internal medicine pharmacists at a large quaternary academic medical center;comparative analysis of pharmacologic treatments for new onset insomnia in hospitalized adult patients;venous thromboembolism prophylaxis with enoxaparin versus unfractionated heparin in patients with low body weight;efficacy of apixaban loading doses post parenteral anticoagulation for venous thromboembolism;real-world impact of continuous glucose monitoring in non-insulin treated type 2 diabetes;expanding the scope at medication management service clinics through a patient recruitment initiative;impact of clinic-provided home blood pressure monitors during COVID-19 pandemic on blood pressure in underserved adults over 50 years old;and PCMH pharmacist impact of quality care measures for patients with uncontrolled type 2 diabetes (T2D).

NIGHT SWEATS IN AN ELDERLY FEMALE

CASE: 74 year old woman with history of anxiety, depression, and nonsecretory adrenal adenoma presented with two months of progressive night sweats. Initially, she described waking up damp all over, but without needing to change her sheets. Her weight had been stable, and she denied recent travel. Her recent health changes included starting sertraline and receiving the Moderna COVID vaccines. Her other medications included atorvastatin and lisinopril. Her vital signs were all within normal range and her physical exam was unremarkable. Night sweats described were mild, so work up began with checking a CBC with differential and a TSH level. Initial labs were normal. However, the patient called a week later with night sweats that were worsening. She also recalled being treated for tuberculosis at age fifteen. This prompted additional bloodwork including Quantiferon, ACTH, androstenedione, estradiol, testosterone, progesterone, and DHEAS levels, as well as urine catecholamines and metanephrines. Additionally, it was noted sertraline could be a potential cause of night sweats. The dose was halved with the goal to taper off and discontinue the medication. All lab results came back within normal limits, so CT scans of the chest/ abdomen/ pelvis were ordered, and blood cultures collected. Imaging showed an unchanged adrenal adenoma and blood cultures had no growth. Ultimately, after five months of symptoms, her night sweats completely resolved five weeks after stopping sertraline. IMPACT/DISCUSSION: When working up night sweats, first, the severity of symptoms should be determined and medications reviewed. Mild night sweats with no associated red flag symptoms (weight loss, lymphadenopathy, and fever) do not need immediate or extensive work up. Further work up is essential in the setting of any red flag symptoms. Without a clear etiology, the work up includes the following items: chest radiography along with bloodwork including Quantiferon test, CBC, TSH, HIV serology, and CRP. If these results are normal then a CT of the chest, abdomen, and pelvis could be obtained as well as a bone marrow biopsy. Little evidence exists to guide an exact order of workup for night sweats, so it remains the clinician's responsibility to determine which tests to prioritize. Classes of medications that tend to cause night sweats are cholinergics and anti-depressants. Anti-depressants most associated with night sweats include TCAs and SNRIs. Sertraline has been implicated as a cause of night sweats, but little data exists as to how often this occurs and how often severe presentations like the one described occur. Given that selective serotonin reuptake inhibitors are a first line treatment in depression, recognizing this adverse effect is important in primary care and could prevent unnecessary extensive work ups for night sweats. CONCLUSION: -An initial step in evaluating persistent night sweats should be medication review -Many antidepressants including sertraline can have night sweats as an adverse effect.

Abstracts 8th PCNE Working Symposium 'Navigating Research on Pharmaceutical Care'

The proceedings contain 62 papers. The topics discussed include: key stakeholders' experiences with the implementation of medication reviews in community pharmacies: a systematic review;screening for patients with hepatitis C in Swiss community pharmacies: a pilot study;effect of a pharmacist-led intervention on the quality of drug treatment;impact of pharmacist-led medication reconciliation on healthcare utilization: a controlled clinical trial;development and psychometric validation of the CONTACT-patient-centered care questionnaire;co-creation of an intervention to increase medication safety among vulnerable migrants;implementation fidelity of a pharmacist-led transitional pharmaceutical care program: process evaluation of the march study;management of acute upper respiratory infections during the COVID-19 pandemic: challenges for community pharmacies;continuity of care after hospital discharge in type 2 diabetic polymorbid patients;and pharmacy owners' views and experiences with the implementation of medication reviews in German community pharmacies: a qualitative study.