11-Year Trend in Antibiotic Consumption in a South-Eastern European Country; the Situation in Albania and the Implications for the Future.

There are growing concerns with rising antimicrobial resistance (AMR) across countries. These concerns are enhanced by the increasing and inappropriate utilization of 'Watch' antibiotics with their greater resistance potential, AMR is further exacerbated by the increasing use of antibiotics to treat patients with COVID-19 despite little evidence of bacterial infections. Currently, little is known about antibiotic utilization patterns in Albania in recent years, including the pandemic years, the influence of an ageing population, as well as increasing GDP and greater healthcare governance. Consequently, total utilization patterns in the country were tracked from 2011 to 2021 alongside key indicators. Key indicators included total utilization as well as changes in the use of 'Watch' antibiotics. Antibiotic consumption fell from 27.4 DIDs (defined daily doses per 1000 inhabitants per day) in 2011 to 18.8 DIDs in 2019, which was assisted by an ageing population and improved infrastructures. However, there was an appreciable increase in the use of 'Watch' antibiotics during the study period. Their utilization rose from 10% of the total utilization among the top 10 most utilized antibiotics (DID basis) in 2011 to 70% by 2019. Antibiotic utilization subsequently rose after the pandemic to 25.1 DIDs in 2021, reversing previous downward trends. Alongside this, there was increasing use of 'Watch' antibiotics, which accounted for 82% (DID basis) of the top 10 antibiotics in 2021. In conclusion, educational activities and antimicrobial stewardship programs are urgently needed in Albania to reduce inappropriate utilization, including 'Watch' antibiotics, and hence AMR.

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.

The impact of the COVID-19 pandemic on antibiotic consumption and prevalence of pathogens in primary and secondary healthcare settings in Northern Ireland.

AIM: To evaluate the impact of the COVID-19 pandemic on the patterns of antimicrobial use and the incidence of pathogens in primary and secondary healthcare settings in Northern Ireland. METHODS: Data were collected on antibiotic use and Gram-positive and Gram-negative pathogens from primary and secondary healthcare settings in Northern Ireland for the period before (January 2015-March 2020) and during (April 2020-December 2021) the pandemic. Time series intervention analysis methods were utilized. RESULTS: In the hospital setting, the mean total hospital antibiotic consumption during the pandemic was 1864.5 defined daily doses (DDDs) per 1000 occupied-bed days (OBD), showing no significant change from pre-pandemic (P = .7365). During the pandemic, the use of second-generation cephalosporins, third-generation cephalosporins, co-amoxiclav and levofloxacin increased, there was a decrease in the percentage use of the hospital Access group (P = .0083) and an increase in the percentage use of Watch group (P = .0040), and the number of hospital Klebsiella oxytoca and methicillin-susceptible Staphylococcus aureus cases increased. In primary care, the mean total antibiotic consumption during the COVID-19 pandemic was 20.53 DDDs per 1000 inhabitants per day (DID), compared to 25.56 DID before the COVID-19 pandemic (P = .0071). During the pandemic, there was a decrease in the use of several antibiotic classes, an increase in the percentage use of the Reserve group (P = .0032) and an increase in the number of community-onset Pseudomonas aeruginosa cases. CONCLUSION: This study provides details of both changes in antibiotic consumption and the prevalence of infections in hospitals and primary care before and during the COVID-19 pandemic that emphasize the importance of antimicrobial stewardship in pandemic situations.

Characterising the treatment of thromboembolic events after COVID-19 vaccination in 4 European countries and the US: An international network cohort study.

Background: Thrombosis with thrombocytopenia syndrome (TTS) has been identified as a rare adverse event following some COVID-19 vaccines. Various guidelines have been issued on the treatment of TTS. We aimed to characterize the treatment of TTS and other thromboembolic events (venous thromboembolism (VTE), and arterial thromboembolism (ATE) after COVID-19 vaccination and compared to historical (pre-vaccination) data in Europe and the US. Methods: We conducted an international network cohort study using 8 primary care, outpatient, and inpatient databases from France, Germany, Netherlands, Spain, The United Kingdom, and The United States. We investigated treatment pathways after the diagnosis of TTS, VTE, or ATE for a pre-vaccination (background) cohort (01/2017-11/2020), and a vaccinated cohort of people followed for 28 days after a dose of any COVID-19 vaccine recorded from 12/2020 onwards). Results: Great variability was observed in the proportion of people treated (with any recommended therapy) across databases, both before and after vaccination. Most patients with TTS received heparins, platelet aggregation inhibitors, or direct Xa inhibitors. The majority of VTE patients (before and after vaccination) were first treated with heparins in inpatient settings and direct Xa inhibitors in outpatient settings. In ATE patients, treatments were also similar before and after vaccinations, with platelet aggregation inhibitors prescribed most frequently. Inpatient and claims data also showed substantial heparin use. Conclusion: TTS, VTE, and ATE after COVID-19 vaccination were treated similarly to background events. Heparin use post-vaccine TTS suggests most events were not identified as vaccine-induced thrombosis with thrombocytopenia by the treating clinicians.

Prescription trends of antiseizure medications before and during the COVID-19 pandemic.

Introduction: Given the lack of evidence on how the COVID-19 pandemic impacted antiseizure medication (ASM) use, we examined the trends of ASMs before and during COVID-19. Methods: We conducted a population-based study using provincial-level health databases from Manitoba, Canada, between 1 June 2016 and 1 March 2021. We used interrupted time series autoregressive models to examine changes in the prevalence and incidence of ASM prescription rates associated with COVID-19 public health restrictions. Results: Among prevalent users, the COVID-19 pandemic led to a significant increase in new-generation ASMs with a percentage change of 0.09% (p = 0.03) and a significant decrease in incidence use of all ASMs with a percentage change of -4.35% (p = 0.04). Significant trend changes were observed in the prevalent use of new-generation ASMs (p = 0.04) and incidence use of all (p = 0.04) and new-generation ASMs (p = 0.02). Gabapentin and clonazepam prescriptions contributed 37% of prevalent and 54% of incident use. Conclusion: With the introduction of public health measures during COVID-19, small but significant changes in the incident and prevalent use of ASM prescriptions were observed. Further studies are needed to examine whether barriers to medication access were associated with potential deterioration in seizure control among patients. Conference presentation: The results from this study have been presented as an oral presentation at the 38th ICPE, International Society of Pharmacoepidemiology (ISPE) annual conference in Copenhagen.

Postmarketing data collection and evidence evaluation

AIFA Monitoring Registries (wMRs) constitute a collection of drug registries (product registries) deployed to physicians and pharmacists through a national web platform. They have been adopted in the clinical practice since 2005 and are used to define the population for which the drug is available under the umbrella of the National Health Service (NHS - Servizio Sanitario Nazionale SSN), monitor prescription appropriateness and ensure the rapid access to potentially priority medicines allowing the implementation of patient-based managed entry agreements (MEAs). Each registry consists of specific data entry forms, collecting data at the patient level and filled in by authorized clinicians and pharmacists. The required information includes: 1. Registration form with patient personal data (anonymized after registration);2. Eligibility and clinical data form;3. Prescription and administration forms;4. Evaluation of disease status and treatment update form;and 5. End-of-treatment form. Evaluation and end-of-treatment forms provide main safety and effectiveness data at a patient level. Moreover, since entry forms are the same throughout the nation, this platform allows access to treatment in a homogeneous manner throughout the country. Recently, a new type of registry has been released, with the primary aim of monitoring the pregnancy prevention programme (PPP) following the prescription of potentially teratogenic medicinal products. All this information is collected in a national database that represents a key source of postmarketing evidence that is frequently exploited to answer both administrative and clinical questions, such as drug utilization among a specific pharmacological class or the effectiveness of a drug in a census consisting of all Italian patients treated with that medicinal product. For example, given the prospective nature of the data contained inside the wMRs, AIFA together with members of the relevant scientific associations were able to evaluate the effect of the COVID- 19 pandemic and lockdown measures on the new prescription (i.e. first prescription) of some cardiovascular drugs in Italy and suggest new studies to analyse the occurrence of new cardiovascular- related events resulting from the decline in the activation of these treatments. Equally important is the work assessing the effectiveness of tyrosine kinase inhibitors in chronic myeloid leukaemia (CML) patients in Italian clinical practice, which was able to highlight important aspects on both expected mortality and consequential use in first and second line TKIs in Italy. Finally, the wMRs were also a critical instrument in the management of the COVID-19 medicinal products since 29 October 2020, providing essential evidence on drug availability through the country, predicting possible shortages and publishing hundreds of freely available reports on the utilization trend of COVID-19 drugs in the different Italian Regions. In conclusion, the wMRs represent a key tool to generate pharmaco-epidemiological evidences in the Real-world setting and monitoring drug appropriateness for expensive, innovative drug.

Impact of Integrative Therapies on Patients with Metastatic Breast Cancer

Background: Integrative therapies are shown to support cancer patients' treatment plans, help with side effect management, and improve patients' quality of life ([1-9]). In 2017, the American Society of Clinical Oncology endorsed the Association of Integrative Oncology's Clinical Practice Guidelines highlighting their importance in breast cancer care. Recent studies suggest that more evidence is needed to bring attention to the role of integrative therapies in advanced breast cancer care [4, 7, 8, 10]. This analysis explores participants' experiences with a wellness program implemented by Unite for HER (UFH), a non-profit organization that delivers integrative therapies and support services such as whole food nutrition services, medical acupuncture, oncology massage therapy, counseling, reiki, meditation, yoga, and fitness classes to patients with breast, metastatic breast, and ovarian cancer. As of April 2022, there were over 1,700 women diagnosed with metastatic breast cancer (MBC) participating in UFH locally and nationally. Method(s): UFH members completed a survey about the impact of the UFH Wellness Program on the overall quality of life, including measures on side-effect management, OTC/prescription drug utilization rate, stress reduction, changes to wellness habits, and the social and emotional challenges associated with living with MBC. In total, 119 unique UFH members with MBC answered online surveys distributed by email in 2020 and 2021. Survey questions were designed to evaluate the impact of the UFH Wellness Program. Descriptive analyses of survey questions and openended comments were conducted to assess program impact. Result(s): All respondents were MBC patients/survivors. No other demographic information was collected. While 2020 respondents received mostly in-person services for part of their program, all 2021 respondents received primarily virtual services due to the Covid-19 restrictions. Despite the inaccessibility of in-person services, the satisfaction levels with the wellness program did not drop significantly in 2021. More than two-thirds of respondents (80% in 2020, 67% in 2021) indicated that the therapies offered through UFH Wellness Program significantly improved the side effects of their treatment for MBC. Notably, more than a quarter of respondents (28% in 2020, 26% in 2021) specified that due to UFH integrative therapies they were able to reduce or eliminate one or more OTC/prescription drugs to manage side effects. At the same time, the majority reported experiencing reduced levels of stress after utilizing integrative therapies offered by UFH (93% in 2020, 81% in 2021), as well as improvements in their emotional wellbeing (95% in 2020, 83% in 2021), and quality of life during or after treatment for MBC (97% in 2020, 96% in 2021). Also, 86% of respondents in both years indicated that UFH services, such as nutrition counseling, cooking classes, and exercise classes, helped them adopt and maintain healthier habits in their life. Furthermore, a qualitative analysis of open-ended comments found that 1) respondents expressed deep gratitude and appreciation for UFH integrative therapies, 2) noted that they would otherwise not be able to access such therapies due to financial barriers, and 3) helped them feel better prepared to cope with the psychosocial aspects of their MBC experience. Discussion(s): These results suggest that integrative therapies such as those offered by UFH can play a significant role in improving patients' outcomes by reducing stress and drug utilization to manage side effects and improving patients' well-being and quality of life during metastatic breast cancer treatment. These findings highlight the importance of choosing integrative oncology programs to support MBC patients' needs in managing the psychosocial and physical side effects of the disease.

Social media and internet search data to inform drug utilization: A systematic scoping review.

Introduction: Drug utilization is currently assessed through traditional data sources such as big electronic medical records (EMRs) databases, surveys, and medication sales. Social media and internet data have been reported to provide more accessible and more timely access to medications' utilization. Objective: This review aims at providing evidence comparing web data on drug utilization to other sources before the COVID-19 pandemic. Methods: We searched Medline, EMBASE, Web of Science, and Scopus until November 25th, 2019, using a predefined search strategy. Two independent reviewers conducted screening and data extraction. Results: Of 6,563 (64%) deduplicated publications retrieved, 14 (0.2%) were included. All studies showed positive associations between drug utilization information from web and comparison data using very different methods. A total of nine (64%) studies found positive linear correlations in drug utilization between web and comparison data. Five studies reported association using other methods: One study reported similar drug popularity rankings using both data sources. Two studies developed prediction models for future drug consumption, including both web and comparison data, and two studies conducted ecological analyses but did not quantitatively compare data sources. According to the STROBE, RECORD, and RECORD-PE checklists, overall reporting quality was mediocre. Many items were left blank as they were out of scope for the type of study investigated. Conclusion: Our results demonstrate the potential of web data for assessing drug utilization, although the field is still in a nascent period of investigation. Ultimately, social media and internet search data could be used to get a quick preliminary quantification of drug use in real time. Additional studies on the topic should use more standardized methodologies on different sets of drugs in order to confirm these findings. In addition, currently available checklists for study quality of reporting would need to be adapted to these new sources of scientific information.

Use of psychotropic drugs in the elderly in France: Are we condemned to remain at high tide?

Psychotropics are widely used drugs, especially in the elderly, especially in France. This, and the risks associated to their use, logically led to concerns that resulted in numerous studies, reports, and regulatory actions intending to limit this use. This review objective was to provide an overview of psychotropic use in elderly subjects in France for antipsychotics, antidepressants, and benzodiazepines and related drugs. The narrative review performed is structured in two parts. The first reminds the initial steps of psychotropic use monitoring in the general French population. The second provides information on psychotropic use in elderly in France using the latest open data released by the French Health Insurance system and processed using the dedicated DrugSurv tool developed within the DRUGS-SAFE® and DRUGS-SAFE® programs. This was completed examining the most recent studies regarding psychotropic use in elderly in France, whether they consisted in publications or reports. At least before the COVID-19 epidemic, decreases in psychotropic prevalence of use among the elderly in France could be observed, mostly for antipsychotics or benzodiazepines (e.g. antipsychotics, 2006-2013: 10.3% decrease and benzodiazepines 2012-2020: decrease from 30.6% to 24.7% in subjects aged ≥65). Psychotropic prevalence of use remained however very high overall (e.g. antidepressants, 2013: 13% in subjects aged 65-74 and 18% in aged ≥65), exceeding that of most other countries, with a significant proportion of inappropriate use (e.g. in 30% of benzodiazepine users, all ages) carrying a clearly identified risks for uncertain benefit. Initiatives have been multiplied at the national level to reduce psychotropic overuse in the elderly. The reported prevalences demonstrate their effectiveness is obviously insufficient. This limited effectiveness is not specific to psychotropics and might reside in a failure to create strong adherence to messages and recommendations. Other levels should be considered, especially regional, for interventions coupled with pharmacoepidemiologic monitoring allowing impact assessment.

Drug utilization in patients with SARS-CoV-2 in an intensive care unit

Context: Prescription indication studies allow identifying the problems that arise during the use of the drug. Aims: To evaluate the treatments used in patients diagnosed with SARS-CoV-2 infection hospitalized in critical care service, through a prescription indication study.Methods: A longitudinal observational study of medication use of the indication-prescription type with elements of the therapeutic scheme and practical consequences was carried out. The sample was characterized from the sociodemographic, clinical, and pharmacotherapeutic points of view. The prescription was evaluated through the indicators: indication, therapeutic scheme, treatment individualization, and drug combinations. The detected adverse reactions were classified according to their causality by the Naranjo Algorithm, their severity, their clinical significance, and according to their mechanism by Rawlins and Thompson.Results: In the sample (n = 77), the male gender predominated (79%) between 27-59 years old (64%), alcohol consumer (62%), hypertensive (33%) with long hospital stay (51%). A total of 417 medications were analyzed, being antibiotics (50.6%) the most prescribed. 73.4% of the therapeutic schemes were correct;however, 26.6% had problems with the therapeutic schemes due to incorrect doses, intervals, duration of treatment, and risky interactions. According to Rawlins and Thompson, two probable adverse reactions were detected, mild, non-serious, and type A and B.Conclusions: The results obtained will allow the pharmaceutical professional to create risk matrices that guarantee a timely intervention in the health team to contribute to the rational and safe use of medicines in patients infected with SARS-CoV-2.

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

A Study on drug utilization pattern of antifibrotic agents in patients with post-COVID-19 lung fibrosis

Pulmonary fibrosis after COVID-19 is a serious consequence that can result in lifelong lung damage or death. A cytokine storm induced by an abnormal immune mechanism may cause the onset and progression of pulmonary fibrosis. Early detection may assist to avoid or at least slow the progression of the disease. Anti-fibrotic agents are widely used drugs in post-COVID-19 pulmonary fibrosis. There are some well-known clinical agents including Pirfenidone and Nintedanib that can be given to COVID-19 patients to prevent further progression of fibrosis and as prophylaxis as well. This study showed the use of antifibrotic therapy in SARS-CoV-2 infection, which is very officious in minimizing and avoiding fibrotic damage induced by inflammatory immune dysfunction. Evidently, pirfenidone has shown its pleiotropic effectivity to decrease the inflammation and oxidative reactive shock associated with fibrosis. Nintedanib binds to the targeted receptors' intracellular ATP pockets, inhibiting pro-fibrotic signaling and reducing fibroblast proliferation, migration, and differentiation, as well as secretion of extracellular matrix components. Copyright © 2023, Anka Publishers. All rights reserved.

Utilization of antidepressants, anxiolytics, and hypnotics during the COVID-19 pandemic in Scandinavia.

OBJECTIVE: To study patterns of antidepressant, anxiolytic, and hypnotic drug utilization in Denmark, Norway, and Sweden during the first year of the COVID-19 pandemic. METHODS: The monthly observed number of prescription fills of antidepressants, benzodiazepines and benzodiazepine-related hypnotics (BZ), and other anxiolytics and hypnotics (OAH) per population in 2020 were compared with predicted numbers based on analysis of covariance of prescription fills during 2015-2019. RESULTS: In March 2020, there was an increased number of prescription fills for antidepressants, anxiolytics, and hypnotics in youths and adults aged 20-59 years in Denmark, Norway, and Sweden. Antidepressant prescription fills increased between 13.5 % and 31.3 % at the end of 2020 in all age groups in Denmark and 17.4 % in youths in Norway. BZ drug prescription fills increased by 20.8 % at the end of 2020 in the 20-59 year age group in Denmark and decreased by 16.7 % in youths in Sweden. A general increase of prescription fills of OAH at the end of 2020 was observed in all countries (range 24.0-80.0 % in Denmark, 11.5-30.8 % in Norway, and 9.1-12.1 % in Sweden). Increases of prescription fills of OAH occurred earlier in Denmark. LIMITATIONS: Aggregated data with lack of information on indications. CONCLUSIONS: Peaks of utilization of antidepressants, anxiolytics, and hypnotics observed in March 2020 may reflect medication stock piling. Increased antidepressant drug utilization in Denmark and in Norwegian youths together with the general increase in OAH utilization in the Scandinavian countries in late 2020 may indicate an increase of symptoms of depression and anxiety, as well as disturbed sleep.

Where did Brazilians get their diabetes drugs during the COVID-19 pandemic? DIABETESvid results

Access to diabetes medications is critical to disease control. However, social distancing in the COVID-19 pandemic may have limited the provision of medicines and supplies. Thus, the objective of this study was to analyze the sources of obtaining diabetes drugs in the COVID-19 pandemic in Brazil. The data came from the DIABETESvid survey, and this analysis considered a convenience sample of 1608 participants who responded to the questionnaire published on social media of scientific societies related to diabetes. This is a cross-sectional study, conducted in the form of a web survey, from September 1 to October 19, 2020. The outcome analyzed was the sources for obtaining diabetes drugs categorized in pharmacies of the "Sistema Único de Saúde", pharmacies of the "Aqui tem Farmácia Popular” program, as well as private pharmacies and drugstores and other sources. Most participants self-reported a diagnosis of type 1 diabetes mellitus (49.8%), used insulin (61.9%), and had a private health plan (68.7%). Private pharmacies and drugstores and other sources were the main places where medicines for diabetes were supplied (47.5%). Participants residing in the Midwest region of the country had a lower frequency of supply in pharmacies in the "Aqui tem Farmácia Popular” program (0.57;95%CI 0.36-0.92). In the studied sample, there was a higher frequency of supply of diabetes drugs in private pharmacies and drugstores and other sources with a reduction in frequency in public pharmacies during the COVID-19 pandemic in Brazil. © 2022 Centro Universitario Sao Camilo. All rights reserved.

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.