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1.
Rev. esp. patol ; 57(1): 42-47, ene.-mar. 2024. ilus, tab
Article in English | IBECS | ID: ibc-EMG-539

ABSTRACT

Subsequent to mass vaccination programs against COVID-19, diverse side effects have been described, both at the injection site, such as pain, redness and swelling, and systemic effects such as fatigue, headache, muscle or joint pain. On rare occasions, a lymphadenopathic syndrome may develop, raising the clinical suspicion of a lymphoproliferative disorder. We present the case of a 30-year-old woman who developed self-limiting left axillary lymphadenopathy following COVID-19 vaccination. To date, only seven similar cases with a complete clinicopathological description have been published, and fourteen cases have been notified to the European adverse events databases (Eudravigilance) in relationship with vaccination against COVID-19. It is important to be aware of this potential complication when a lymphadenopathic syndrome develops following vaccination, to avoid unnecessary treatment. (AU)


Tras la vacunación masiva frente a la COVID-19 se han comenzado a describir diversos efectos adversos incluyendo efectos locales en el lugar de la inyección, como dolor, enrojecimiento, hinchazón, etc., y efectos sistémicos como fatiga, dolor de cabeza, dolor muscular o articular. Más infrecuentemente se pueden desarrollar cuadros linfadenopáticos sospechosos clínicamente de proceso linfoproliferativo. Presentamos el caso de una mujer de 30 años que desarrolló linfadenopatía axilar izquierda tras la vacunación contra la COVID-19 con hallazgos histopatológicos de linfadenopatía necrotizante de tipo Kikuchi y resolución espontánea. Hasta el momento se han publicado 7 casos con descripción clinicopatológica completa en la literatura y notificado 14 casos en la Red Europea de Farmacovigilancia en relación con la vacunación. Es importante tener en cuenta esta entidad en linfadenopatías sospechosas de procesos linfoproliferativos en este contexto, para evitar un tratamiento innecesario. (AU)


Subject(s)
Humans , Female , Adult , Coronavirus Infections/epidemiology , Mass Vaccination/adverse effects , Histiocytic Necrotizing Lymphadenitis
2.
Arch Bronconeumol ; 60(3): 161-170, 2024 Mar.
Article in English, Spanish | MEDLINE | ID: mdl-38311509

ABSTRACT

Respiratory syncytial virus (RSV) is a major cause of respiratory tract infections in adults, particularly older adults and those with underlying medical conditions. Vaccination has emerged as a potential key strategy to prevent RSV-related morbidity and mortality. This Neumoexperts Prevention (NEP) Group scientific paper aims to provide an evidence-based positioning and RSV vaccination recommendations for adult patients. We review the current literature on RSV burden and vaccine development and availability, emphasising the importance of vaccination in the adult population. According to our interpretation of the data, RSV vaccines should be part of the adult immunisation programme, and an age-based strategy should be preferred over targeting high-risk groups. The effectiveness and efficiency of this practice will depend on the duration of protection and the need for annual or more spaced doses. Our recommendations should help healthcare professionals formulate guidelines and implement effective vaccination programmes for adult patients at risk of RSV infection now that specific vaccines are available.


Subject(s)
Respiratory Syncytial Virus Infections , Respiratory Syncytial Virus, Human , Respiratory Tract Infections , Humans , Middle Aged , Aged , Respiratory Syncytial Virus Infections/epidemiology , Respiratory Syncytial Virus Infections/prevention & control , Vaccination
3.
Int J Risk Saf Med ; 35(1): 49-73, 2024.
Article in English | MEDLINE | ID: mdl-38363621

ABSTRACT

BACKGROUND: The global COVID-19 pandemic has forced people to obtain health products and services from home. Similar to other e-commerce, medicines are bought online and delivered using a courier service. OBJECTIVE: By being fully concerned to patient safety, this study aims to determine development strategies to increase intention in purchasing prescription drugs through e-pharmacy. METHODS: Two stages of measurement are employed in this study, namely confirmatory factor analyis using PLS-SEM and pairwise comparison using AHP method. To discover consumer perception in using e-pharmacy, the basic model of Theory of Planned Behavior (TPB) is employed with several extensions. RESULTS: The results of PLS-SEM express that Trust has a major role as an intervening variable to enhance the indirect effect of Subjective Norms and Perceived Values on Purchase Intention. In general, PLS-SEM structural model is declared "fit" (GFI = 0.93 ≥ 0.90; RMSEA = 0.045 ≤ 0.08; SRMR = 0.033 ≤ 0.05). Measurement model test proves that all selected indicators are valid to represent their related constructs (Loading Factor ≥ 0.50), and all selected constructs are reliable to build the whole path model (CR ≥ 0.7; AVE ≥ 05). Meanwhile, the results of AHP indicate that strengthening government policies and regulations is prioritized to increase consumer intention of purchasing prescription drugs through e-pharmacy, followed by protection of user confidential data in the second place. Those two eigenvectors are 0.236 and 0.185 respectively. CONCLUSION: Future research is suggested to add perceived risk as latent variable in the study of consumer behavior for any high-risk products.


Subject(s)
Pharmacy , Prescription Drugs , Humans , Indonesia , Consumer Behavior , Intention , Pandemics , Prescriptions
4.
Microbiol Spectr ; 12(3): e0243523, 2024 Mar 05.
Article in English | MEDLINE | ID: mdl-38319108

ABSTRACT

It is urgently needed to evaluate the necessity and benefits of booster vaccination against the coronavirus 2 of the severe acute respiratory syndrome (SARS-CoV-2) Omicron to facilitate clinical decision-making for 2019 coronavirus disease (COVID-19) convalescents. We conducted a multicenter, prospective clinical trial (registration number: ChiCTR2100045810) in the first patients with COVID-19 from 28 January 2020 to 20 February 2020 to assess the long-term durability of neutralizing antibodies against live Omicron BA.5 and further assess the efficiency and safety of CoronaVac in the convalescent group. A total of 96 COVID-19 convalescents were enrolled in this study. Neutralizing antibody titers in convalescents were significantly reduced in 9-10 months. A dose-refreshing vaccination in 28 convalescents with an antibody titer below 96 significantly induced neutralizing antibodies against live Omicron by 4.84-fold. Meanwhile, the abundance of naive T cells increased dramatically, and TEMRA and TEM cells gradually decreased after vaccination. Activation-induced cell death and apoptosis-related genes were significantly elevated after vaccination in all T-cell subtypes. One-dose booster vaccination was effective in inducing a robust antibody response against SARS-CoV-2 Omicron in COVID-19 convalescents with low antibody titers. However, vaccine-mediated T-cell consumption and regeneration patterns may be detrimental to the antiviral response.IMPORTANCEThe globally dominant coronavirus 2 of the severe acute respiratory syndrome (SARS-CoV-2) Omicron variant raises the possibility of repeat infections among 2019 coronavirus disease (COVID-19) convalescents with low neutralizing antibody titers. The importance of this multicenter study lies in its evaluation of the long-term durability of neutralizing antibodies in COVID-19 convalescents and the efficacy of a booster vaccination against the live Omicron. The findings suggest that a one-dose booster vaccination is effective in inducing a robust antibody response against SARS-CoV-2 Omicron in convalescents with low antibody titers. However, the study also highlights the potential detrimental effects on the antiviral response due to vaccine-mediated T-cell consumption and regeneration patterns. These results are crucial for facilitating clinical decision-making for COVID-19 convalescents and informing public health policies regarding booster vaccinations.


Subject(s)
COVID-19 , Humans , Antibodies, Neutralizing , Antibodies, Viral , Antiviral Agents , Apoptosis , COVID-19/prevention & control , Prospective Studies , SARS-CoV-2 , T-Lymphocytes , Vaccination , Vaccines, Inactivated
5.
EBioMedicine ; 100: 104987, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38306894

ABSTRACT

BACKGROUND: Elicitation of broad immune responses is understood to be required for an efficacious preventative HIV vaccine. This Phase 1 randomized controlled trial evaluated whether administration of vaccine antigens separated at multiple injection sites vs combined, fractional delivery at multiple sites affected T-cell breadth compared to standard, single site vaccination. METHODS: We randomized 90 participants to receive recombinant adenovirus 5 (rAd5) vector with HIV inserts gag, pol and env via three different strategies. The Standard group received vaccine at a single anatomic site (n = 30) compared to two polytopic (multisite) vaccination groups: Separated (n = 30), where antigens were separately administered to four anatomical sites, and Fractioned (n = 30), where fractions of each vaccine component were combined and administered at four sites. All groups received the same total dose of vaccine. FINDINGS: CD8 T-cell response rates and magnitudes were significantly higher in the Fractioned group than Standard for several antigen pools tested. CD4 T-cell response magnitudes to Pol were higher in the Separated than Standard group. T-cell epitope mapping demonstrated greatest breadth in the Fractioned group (median 8.0 vs 2.5 for Standard, Wilcoxon p = 0.03; not significant after multiplicity adjustment for co-primary endpoints). IgG binding antibody response rates to Env were higher in the Standard and Fractioned groups vs Separated group. INTERPRETATION: This study shows that the number of anatomic sites for which a vaccine is delivered and distribution of its antigenic components influences immune responses in humans. FUNDING: National Institute of Allergy and Infectious Diseases, NIH.


Subject(s)
AIDS Vaccines , HIV Infections , Humans , Epitopes , CD4-Positive T-Lymphocytes , Vaccination , Immunoglobulin G
6.
Res Social Adm Pharm ; 20(4): 432-442, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38302297

ABSTRACT

The objective of this cross-sectional analysis was to identify determinants of increasing medicine expenditures in the US between 2011 and 2020. Prescription medication expenditures from the 2011-2020 Medical Expenditures Panel Survey (MEPS) were used to calculate total annual medication expenditures by payer categories (Out-of-pocket, Medicare, Medicaid, TRICARE/Veterans Administration/CHAMPVA (TVAC), Other Government Sources, Private Insurance, and Other Sources). From here, expenditures were stratified by therapeutic category using Multum Lexicon Drug Class to examine trends in expenditures by therapeutic area. Linear regression was used to identify temporal trends in medication expenditures. From 2011 to 2020, total annual prescription medication expenditures rose from $341.49 to $473.12 billion per year with metabolic agents being the most costly category. Among the metabolic agents, antidiabetic agents were the most costly therapeutic area, with an increasing trend observed from $27.15 to $89.17 billion over the same period. Medicare, Medicaid, Private Insurance, TVAC, and Other Sources also saw an increasing trend in antidiabetic agent expenditure, while no trend was observed for Out-of-pocket and Other Government Sources. Insulin had the highest expenditure among antidiabetic agents. Further studies are warranted to explore specific factors contributing to the increasing trend.


Subject(s)
Health Expenditures , Prescription Drugs , Aged , Humans , United States , Medicare , Cross-Sectional Studies , Prescription Drugs/therapeutic use , Hypoglycemic Agents/therapeutic use , Prescriptions
7.
Front Public Health ; 12: 1343064, 2024.
Article in English | MEDLINE | ID: mdl-38299075

ABSTRACT

Introduction: Although the burden of cervical cancer in Africa is highest, HPV vaccination coverage remains alarmingly low in this region. Providers' knowledge and recommendation are key drivers of HPV vaccination uptake. Yet, evidence about providers' knowledge and recommendation practices about the HPV vaccine against a backdrop of emerging vaccine hesitancy fueled by the COVID-19 pandemic is lacking in Africa. Methods: A cross-sectional study was conducted in 2021-2022 among healthcare providers involved in cervical cancer prevention activities in Africa. They were invited to report prior training, the availability of the HPV vaccine in their practice, whether they recommended the HPV vaccine, and, if not, the reasons for not recommending it. Their knowledge about the HPV vaccine was assessed through self-reporting (perceived knowledge) and with three pre-tested knowledge questions (measured knowledge). Results: Of the 153 providers from 23 African countries who responded to the survey (mean age: 38.5 years, SD: 10.1), 75 (54.0%) were female and 97 (63.4%) were based In countries with national HPV immunization programs. Overall, 57 (43.8%) reported having received prior training on HPV vaccine education/counseling, and 40 (37.4%) indicated that the HPV vaccine was available at the facility where they work. Most respondents (109, 83.2%) reported recommending the HPV vaccine in their practice. Vaccine unavailability (57.1%), lack of effective communication tools and informational material (28.6%), and need for adequate training (28.6%) were the most commonly reported reasons for not recommending the HPV vaccine. While 63 providers (52.9%) reported that their knowledge about HPV vaccination was adequate for their practice, only 9.9% responded correctly to the 3 knowledge questions. Conclusion: To increase HPV vaccination coverage and counter misinformation about this vaccine in Africa, adequate training of providers and culturally appropriate educational materials are needed to improve their knowledge of the HPV vaccine and to facilitate effective communication with their patients and the community.


Subject(s)
COVID-19 , Papillomavirus Infections , Papillomavirus Vaccines , Uterine Cervical Neoplasms , Humans , Female , Adult , Male , Cross-Sectional Studies , Uterine Cervical Neoplasms/prevention & control , Papillomavirus Infections/prevention & control , Pandemics , Vaccination/psychology , Health Knowledge, Attitudes, Practice , COVID-19/prevention & control , Health Personnel , Africa , Papillomavirus Vaccines/therapeutic use
8.
Obstet Gynecol ; 143(4): 484-490, 2024 Apr 01.
Article in English | MEDLINE | ID: mdl-38330405

ABSTRACT

Respiratory syncytial virus (RSV) is a significant cause of infant morbidity and mortality worldwide with peak hospitalization rates for RSV-mediated illnesses between 2 and 3 months of life. Until very recently, prevention strategies for RSV involved primarily passive immunization of neonates at high risk with monoclonal antibodies and promotion of breastfeeding. The Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices now recommends passive immunization of all neonates with monoclonal antibodies during RSV season, and the American Association of Pediatrics has endorsed this practice. The U.S. Food and Drug Administration (FDA) recently approved a vaccination for RSV in pregnancy. The CDC's Advisory Committee on Immunization Practices has recently recommended RSV vaccination for all pregnant patients between 32 and 36 weeks of gestation who are anticipated to deliver during RSV season if they are not planning nirsevimab for their infants. This recommendation has been endorsed by the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine. In this clinical perspective, we review the scientific evidence, potential concerns, challenges, and future considerations for RSV vaccination in pregnancy.


Subject(s)
Respiratory Syncytial Virus Infections , Respiratory Syncytial Viruses , Female , Humans , Infant , Infant, Newborn , Pregnancy , Antibodies, Monoclonal , Immunization , Respiratory Syncytial Virus Infections/prevention & control , Respiratory Syncytial Virus Infections/drug therapy , United States , Vaccination , Practice Guidelines as Topic
9.
Sci Rep ; 14(1): 2801, 2024 02 02.
Article in English | MEDLINE | ID: mdl-38307870

ABSTRACT

Several reports stated that erythema multiforme (EM) was associated with COVID-19 with detrimental outcomes in patients. However, since most of these are case reports, it is challenging to quantitively assess their associations. Therefore, our study aims to determine the prevalence of EM in the context of COVID-19. The study was designed as a retrospective cross-sectional hospital-based study of registered patients at the University of Florida Health Hospital. The ICD-10 codes for EM, COVID-19 infection, and COVID-19 vaccines were searched in the database. The odds ratio was calculated to assess the risk of EM after COVID-19 infection or vaccination. Our study included 43,547 patients with a history of COVID-19 infection, of whom 92 developed EM. Patients with COVID-19 infection were 6.68 times more likely to have EM than those without COVID-19 (P < 0.0001). Similarly, the risk of developing EM after COVID-19 vaccination was 2.7, significantly higher than the general population (P < 0.0001). The prevalence of EM following COVID-19 infection or vaccination significantly differs from the general population, highlighting the importance of monitoring patients for EM after COVID-19 infection and/or vaccination. It is imperative to disseminate awareness to clinicians and patients regarding the impact of COVID-19 on EM.


Subject(s)
COVID-19 , Erythema Multiforme , Humans , COVID-19 Vaccines/adverse effects , Retrospective Studies , Prevalence , Cross-Sectional Studies , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19/complications , Erythema Multiforme/epidemiology , Erythema Multiforme/etiology , Vaccination/adverse effects
10.
JAMA Netw Open ; 7(2): e2354710, 2024 Feb 05.
Article in English | MEDLINE | ID: mdl-38306096

ABSTRACT

Importance: Although New York State (NYS) recently adopted legislation eliminating nonmedical vaccination exemption options from school-entry requirements, the implications of the law for school vaccine coverage and medical vaccine exemption uptake have not been examined. Objective: To evaluate the implications of the repeal of school-entry nonmedical vaccination exemptions for vaccine coverage and medical exemption uptake at NYS schools outside of New York City (NYC). Design, Setting, and Participants: This cohort study had an interrupted time-series design and used generalized estimating equation models to examine longitudinal school immunization compliance data from the 2012 to 2013 through 2021 to 2022 school years. The cohort comprised NYS public and nonpublic schools, excluding NYC schools, with any students enrolled in kindergarten to 12th grade. Eligible schools had enrollment and immunization data before and after the implementation of the Senate Bill 2994A legislation. Data analyses were conducted in July 2023. Exposure: Senate Bill 2994A was passed in June 2019, eliminating school-entry nonmedical vaccination exemptions. Since compliance with the law was evaluated for most students during the next school year, the 2019 to 2020 school year was considered to be the law's effective date. Main Outcomes and Measures: The primary outcomes were school vaccine coverage (defined as the percentage of students at each school who completed grade-appropriate requirements for all required vaccines) and medical exemption uptake (defined as the percentage of students at each school who received a medical exemption). Results: Among the 3821 eligible schools, 3632 (95.1%) were included in the analysis, representing 2794 (96.9% of eligible) public schools and 838 (89.2% of eligible) nonpublic schools. The implementation of Senate Bill 2994A was associated with absolute increases in mean vaccine coverage of 5.5% (95% CI, 4.5%-6.6%) among nonpublic schools and 0.9% (95% CI, 0.7%-1.1%) among public schools, with additional annual increases in vaccine coverage observed through the 2021 to 2022 school year. The law's implementation was also associated with a 0.1% (95% CI, 0.0%-0.1%) mean absolute decrease in medical vaccination exemption uptake at both public and nonpublic schools, and small but significant mean annual decreases in medical vaccination exemptions (0.02%; 95% CI, 0.01%-0.03%) through the end of the study period. Conclusions and Relevance: Results of this cohort study suggested that repeal of school-entry nonmedical vaccination exemptions was associated with increased vaccine coverage at NYS schools outside of NYC. Coverage gains were not replaced by increases in medical vaccination exemptions.


Subject(s)
Vaccination , Vaccines , Humans , Cohort Studies , Schools , New York City
11.
Harm Reduct J ; 21(1): 29, 2024 Feb 04.
Article in English | MEDLINE | ID: mdl-38311717

ABSTRACT

BACKGROUND: People who use drugs (PWUD) experience elevated HIV risk and numerous barriers to facility-based HIV testing. HIV self-testing (HIVST) could circumvent many of those barriers and is acceptable among PWUD, yet HIVST implementation for PWUD is limited. Service providers' perspectives on specific HIVST delivery strategies could help increase availability for PWUD. METHODS: From April-November 2021, we interviewed 16 health, harm reduction, and social service providers working with PWUD in San Diego, CA. Interviews and rapid thematic analysis explored perspectives on HIVST's utility and appropriateness, as well as the feasibility of and anticipated challenges with specific HIVST delivery strategies, including peer or secondary distribution. RESULTS: Participants viewed HIV as a significant threat to PWUD health and confirmed the presence of numerous barriers to local facility-based HIV testing. Participants viewed HIVST as a promising and potentially empowering solution. Based on community familiarity with secondary distribution of harm reduction supplies (i.e., naloxone) and information, participants viewed secondary distribution of HIVST kits as an appropriate and feasible strategy for increasing the reach of HIVST, but also described potential barriers (e.g., engaging socially disconnected individuals, ensuring linkages to services following HIVST) and provided suggestions for alternative HIVST kit delivery models (e.g., harm reduction vending machines). CONCLUSIONS: Service providers viewed secondary distribution of HIVST kits among PWUD as promising, appropriate, and feasible, yet specialized efforts may be needed to reach the most marginalized individuals and ensure consistent provision of educational information and referral supports that maximize the impact of this approach.


Subject(s)
HIV Infections , Harm Reduction , Humans , Self-Testing , Pharmaceutical Preparations , Feasibility Studies , HIV Infections/diagnosis , HIV Infections/prevention & control
12.
Hum Vaccin Immunother ; 20(1): 2301189, 2024 Dec 31.
Article in English | MEDLINE | ID: mdl-38346919

ABSTRACT

High levels of COVID-19 vaccine hesitancy have been reported among Black and Latinx populations, with lower vaccination coverage among racialized versus White sexual and gender minorities. We examined multilevel contexts that influence COVID-19 vaccine uptake, barriers to vaccination, and vaccine hesitancy among predominantly racialized sexual and gender minority individuals. Semi-structured online interviews explored perspectives and experiences around COVID-19 vaccination. Interviews were recorded, transcribed, uploaded into ATLAS.ti, and reviewed using thematic analysis. Among 40 participants (mean age, 29.0 years [SD, 9.6]), all identified as sexual and/or gender minority, 82.5% of whom were racialized. COVID-19 vaccination experiences were dominated by structural barriers: systemic racism, transphobia and homophobia in healthcare and government/public health institutions; limited availability of vaccination/appointments in vulnerable neighborhoods; absence of culturally-tailored and multi-language information; lack of digital/internet access; and prohibitive indirect costs of vaccination. Vaccine hesitancy reflected in uncertainties about a novel vaccine amid conflicting information and institutional mistrust was integrally linked to structural factors. Findings suggest that the uncritical application of "vaccine hesitancy" to unilaterally explain undervaccination among marginalized populations risks conflating structural and institutional barriers with individual-level psychological factors, in effect placing the onus on those most disenfranchised to overcome societal and institutional processes of marginalization. Rather, disaggregating structural determinants of vaccination availability, access, and institutional stigma and mistrust from individual attitudes and decision-making that reflect vaccine hesitancy, may support 1) evidence-informed interventions to mitigate structural barriers in access to vaccination, and 2) culturally-informed approaches to address decisional ambivalence in the context of structural homophobia, transphobia, and racism.


Subject(s)
COVID-19 , Vaccines , Adult , Humans , COVID-19 Vaccines , Hunting , COVID-19/prevention & control , Vaccination , Qualitative Research
13.
Front Public Health ; 12: 1323195, 2024.
Article in English | MEDLINE | ID: mdl-38347924

ABSTRACT

Background: Despite the elevated risks of infection transmission, people in prisons frequently encounter significant barriers in accessing essential healthcare services in many countries. The present scoping review aimed to evaluate the state of availability and model of delivery of vaccination services within correctional facilities across the globe. Methods: Following the methodological framework for scoping reviews and adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) extension for scoping reviews criteria, we conducted a systematic search across four peer-reviewed literature databases (Medline via PubMed, Web of Science, the Cochrane Library, Science Direct, and EBSCO), as well as 14 sources of grey literature. Two researchers meticulously examined the identified papers independently to extract pertinent data published between 2012 and 2022. The quality of the selected publications was assessed using established quality assessment tools. Results: Of the 11,281 identified papers 52 met the inclusion criteria. With the exception of one, all the included publications presented data from high-income countries, predominantly originating from the United States. Across the world, the most prevalent vaccines available in prison settings were COVID-19 and HBV vaccines, typically distributed in response to health crises such as pandemics, epidemics, and local outbreaks. Vaccine coverage and uptake rates within correctional facilities displayed noteworthy disparities among various countries and regions. Besides, individual and organizational barriers and facilitating factors of vaccination in prison settings emerged and discussed in the text. Discussion: The lack of vaccination services combined with low rates of vaccination coverage and uptake among people living and working in correctional facilities represents a cause for concern. Prisons are not isolated from the broader community, therefore, efforts to increase vaccine uptake among people who live and work in prisons will yield broader public health benefits.


Subject(s)
COVID-19 , Communicable Diseases, Emerging , Vaccines , Humans , Communicable Diseases, Emerging/epidemiology , Communicable Diseases, Emerging/prevention & control , Vaccination , Pandemics/prevention & control
14.
Cien Saude Colet ; 29(2): e17702022, 2024 Feb.
Article in Portuguese, English | MEDLINE | ID: mdl-38324836

ABSTRACT

This is an opinion-based article that aims to reflect on the antagonism established between the National Policy of Integral Attention to Men's Health (PNAISH) with specific focus on ED (Erectile Dysfunction), directed to access to medication. It is well-known that PNAISH presents objectives that go beyond sexual and reproductive health, especially, even after 13 years of its publication, since there was no incorporation of medications to treat ED within the SUS. This article was developed based on the scenario observed in the daily care of patients who undergo treatment in the Men's Health Outpatient Service of a High-Complexity Hospital. According to this perspective, it is important to emphasize, that the prescription of medications within the SUS should faithfully follow the Rename; as recommended by Decree 7,508, observing the Resolution SS-83 of 2015, in the state of São Paulo. This establishes that the cost of dispensing medications not included in the SUS pharmaceutical assistance protocols, through judicialization, prescribed by a physician in the state health network, may be funded by the institution to which this physician is affiliated.


Trata-se de um artigo embasado em opinião que procura refletir sobre o antagonismo estabelecido entre a Política Nacional de Atenção Integral à Saúde do Homem (PNAISH) com o recorte específico para DE (Disfunção Erétil) direcionado ao acesso de medicamentos. É notório que a PNAISH apresenta objetivos que vão além da saúde sexual e reprodutiva, sobretudo, mesmo após 13 anos de sua publicação, não houve incorporação de medicamentos para tratar DE no âmbito SUS. O artigo foi desenvolvido com base no cenário observado no dia a dia de atendimento aos pacientes que recebem cuidados no Serviço Ambulatorial da Saúde Masculina de um Hospital de Alta Complexidade. Isto por constatar a dificuldade dos médicos em prescreverem medicamentos para DE, por ausência de padronização no contexto SUS. Importante ressaltar, nesta perspectiva, que a prescrição de medicamentos no âmbito SUS deve seguir fidedignamente a Rename; conforme preconiza o Decreto 7.508 e, se atentar à Resolução SS-83 de 2015, vigente no estado de São Paulo. Ela estabelece que o custo da dispensação de medicamentos não contemplados na Rename, por meio da judicialização, prescritos por médico da rede estadual de saúde, poderá ser custeado pela instituição ao qual este esteja vinculado.


Subject(s)
Erectile Dysfunction , Male , Humans , Erectile Dysfunction/drug therapy , Public Health , Brazil , Prescriptions , Pharmaceutical Preparations , Health Services Accessibility
15.
Ann Ig ; 36(2): 215-226, 2024.
Article in English | MEDLINE | ID: mdl-38299733

ABSTRACT

Background: Subjects with selected underlying medical conditions are at higher risk of infection and severe outcomes from vaccines preventable diseases. While most countries adopt life-course approaches to vaccination, high-risk group immunization programmes could maximize individual protection, while contributing to population health. The COVID-19 pandemic stimulated the planning and implementation of successful hospital-based high-risk groups' immunization models. However, in Italy, high-risk subjects' vaccine coverage is not actively monitored at the national or regional level, nor shared guidelines exist yet on hospital-based immunization programmes. Study Design: The study reports findings from a region-wide assessment of the availability, characteristics, and setting-specific features of hospital-based immunization programmes for high-risk subjects in the Lombardy region. Methods: Fondazione The Bridge a not-for-profit organization based in Milan, in collaboration with the Prevention Unit of the Lombardy Region Directorate for Welfare, and the University of Pavia coordinated a project aimed at bringing together regional health institutions, key stakeholders, academic experts, scientific societies and patients' associations to assess high-risk subjects' barriers to vaccine uptake and inform preventive programmes and policies. In this context, we designed and implemented a survey to systematically map the existence and characteristics of hospital-based immunization programmes targeting high-risk subjects. The survey was proposed to all 115 hospital medical directions of the Lombardy region. Results: We collected data from 97 hospital medical directions, with a response rate of 85%. Among respondents, 24% were publi-cly managed hospitals, 17% were Scientific Institute for Research, Hospitalization and Healthcare (IRCCS) and 59% accredited private hospitals. Overall, 51.5% facilities in the Lombardy Region reported to actively administer vaccines to high-risk subjects in hospital settings, the prevalence being 89.6% in public hospitals. Among hospitals where vaccines are actively administered, 46% reported to have centralized vaccines ambulatory clinics, while 54% reported to administer vaccines in the context of inpa-tient care, within clinical wards. In 14% of hospitals vaccination counselling is carried out at the hospital level, while patients are referred to community services for the vaccine administration, 58% have established clinical pathways and formalized internal procedures to integrate vaccine prevention within the clinical care. Conclusions: Half of hospital facilities in the Lombardy Region administer vaccines to high-risk patients. Hospital-based im-munization models vary widely by vaccines programmes, organizational aspects, vaccines procurement and workforce involved. Identifying best practices and effective models can help tackle current challenges and improve immunization coverage for at-risk groups.


Subject(s)
Pandemics , Vaccines , Humans , Pandemics/prevention & control , Immunization Programs , Vaccination , Italy/epidemiology , Hospitals
16.
J Evol Biol ; 37(2): 189-200, 2024 Feb 14.
Article in English | MEDLINE | ID: mdl-38300809

ABSTRACT

Worldwide inequalities in vaccine availability are expected to affect the spread and spatial distribution of infectious diseases. It is unclear, however, how spatial variation in vaccination coverage can affect the long-term evolution of pathogens. Here we use an analytical model and numerical simulations to analyse the influence of different imperfect vaccines on the potential evolution of pathogen virulence in a two-population model where vaccination coverage varies between populations. We focus on four vaccines, with different modes of action on the life cycle of a pathogen infecting two host populations coupled by migration. We show that, for vaccines that reduce infection risk or transmissibility, spatial heterogeneity has little effect on pathogen prevalence and host mortality, and no effect on the evolution of pathogen virulence. In contrast, vaccines that reduce pathogen virulence can select for more virulent pathogens and may lead to the coexistence of different pathogen strains, depending on the degree of spatial heterogeneity in the metapopulation. This heterogeneity is driven by two parameters: pathogen migration and the difference in the vaccination rate between the two populations. We show that vaccines that only reduce pathogen virulence select mainly for a single pathogen strategy in the long term, while vaccines that reduce both transmission and virulence can favor the coexistence of two pathogen genotypes. We discuss the implications and potential extensions of our analysis.


Subject(s)
Vaccination Coverage , Vaccines , Humans , Virulence/genetics , Disease Susceptibility , Biological Evolution
17.
Res Social Adm Pharm ; 20(5): 475-486, 2024 May.
Article in English | MEDLINE | ID: mdl-38326207

ABSTRACT

BACKGROUND: Pharmacist prescribing has been introduced in several countries as a strategy to improve access to health care and medicines. However, the direct impacts of pharmacist prescribing on medicines access, and the overall accessibility of pharmacist prescribing services, are not well known. OBJECTIVES: This systematic review aimed to assess the direct impacts of pharmacist prescribing on medicines access, and the accessibility of pharmacist prescribing services, in community and primary care settings. METHODS: PubMed, Embase, and CINAHL were searched for studies published in English between 01 January 2003 to 15 June 2023. Both quantitative and qualitative primary studies were included if they described pharmacist prescribing in a primary care setting. Outcomes included findings related to access to medicines as a result of pharmacist prescribing (primary outcome), and access to pharmacist prescribing services overall (secondary outcome). Narrative synthesis of outcomes was undertaken. RESULTS: A total of 47 studies were included from four countries (United States, United Kingdom, Canada, New Zealand). Thirteen studies provided evidence that pharmacist prescribing may improve medicines access in several ways, including: increasing the proportion of eligible people receiving medicines, increasing the number of overall dispensed prescriptions, or reducing time to receipt of treatment. The remainder of the included studies reported on the accessibility of pharmacist prescribing services. Published studies highlight that pharmacist prescribers practicing in community settings are generally accessible, with pharmacist prescribers viewed by patients as easy and convenient to consult. There was limited evidence about the affordability of pharmacy prescribing services, and a number of potential equity issues were observed, including reduced access to pharmacist prescribers in more socioeconomically disadvantaged areas and those with greater proportions of populations at risk of health inequities, such as culturally and linguistically diverse communities. CONCLUSIONS: This systematic review found that pharmacist prescribing services were both highly accessible and beneficial in improving access to medicines. However, measures of medicines access varied, and few studies included direct measures of medicines access as an outcome of pharmacist prescribing, highlighting a need for future studies to incorporate direct measures of medicines access when assessing the impact of pharmacist prescribing services.


Subject(s)
Drug Prescriptions , Pharmaceutical Services , Humans , United States , Pharmacists , Delivery of Health Care , United Kingdom
18.
Pharm Res ; 41(2): 365-374, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38332389

ABSTRACT

PURPOSE: Significant resources are spent on developing robust liquid chromatography (LC) methods with optimum conditions for all project in the pipeline. Although, data-driven computer assisted modelling has been implemented to shorten the method development timelines, these modelling approaches require project-specific screening data to model retention time (RT) as function of method parameters. Sometimes method re-development is required, leading to additional investments and redundant laboratory work. Cheminformatics techniques have been successfully used to predict the RT of metabolites & other component mixtures for similar use cases. Here we will show that these techniques can be used to model structurally diverse molecules and predictions of these models trained on multiple LC conditions can be used for downstream data-driven modelling. METHODS: The Molecular Operating Environment (MOE) was used to calculate over 800 descriptors using the strucutres of the analytes. These descriptors were used to model the RT of the analytes under four chromatographic conditions. These models were then used to create data-driven models using LC-SIM. RESULTS: A structural-based Random Forest (RF) model outperformed other techniques in cross-validation studies and predicted the RTs of a randomized test set with a median percentage error less than 4% for all LC conditions. RTs predicted by this structure-based model were used to fit a data-driven model that identifies optimum LC conditions without any additional experimental work. CONCLUSIONS: These results show that small training sets yield pharmaceutically relevant models when used in a combination of structure-based and data-driven model.


Subject(s)
Chromatography, Liquid , Chromatography, Liquid/methods , Computer Simulation , Pharmaceutical Preparations
19.
PLoS One ; 19(2): e0295226, 2024.
Article in English | MEDLINE | ID: mdl-38330001

ABSTRACT

Patient Support Programmes (PSPs) are used by the pharmaceutical industry to provide education and support to consumers to overcome the challenges they face managing their condition and treatment. Whilst there is an increasing number of PSPs, limited information is available on whether these programmes contribute to safety signals. PSPs do not have a scientific hypothesis, nor are they governed by a protocol. However, by their nature, PSPs inevitably generate adverse event (AE) reports. The main goal of the research was to gather all Novartis-initiated PSPs for sacubitril/valsartan, followed by research in the company safety database to identify all AE reports emanating from these PSPs. Core data sheets (CDS) were reviewed to assess if these PSPs contributed to any new, regulatory-authority approved, validated signals. Overall, AEs entered into the safety database from PSPs confirmed no contribution to CDS updates. Detailed review of real-world data revealed tablet splitting or taking one higher dose tablet a day instead of twice daily. This research, and subsequent analyses, revealed that PSPs did not impact safety label changes for sacubitril/valsartan. It revealed an important finding concerning drug utilisation i.e. splitting of sacubitril/valsartan tablets to reduce cost. This finding suggests that PSPs may contribute important real-world data on patterns of medication usage. There remains a paucity of literature available on this topic, hence further research is required to assess if it would be worth designing PSPs for collecting data on drug utilisation and (lack of) efficacy. Such information from PSPs could be important for all stakeholders.


Subject(s)
Aminobutyrates , Heart Failure , Humans , Valsartan/therapeutic use , Aminobutyrates/therapeutic use , Biphenyl Compounds/therapeutic use , Drug Utilization , Drug Combinations , Tablets/therapeutic use , Heart Failure/drug therapy , Tetrazoles/therapeutic use , Stroke Volume , Angiotensin Receptor Antagonists/therapeutic use
20.
PLoS One ; 19(2): e0296123, 2024.
Article in English | MEDLINE | ID: mdl-38324535

ABSTRACT

BACKGROUND: Age-appropriate vaccination or vaccine timeliness is the administering of vaccines on the specified schedule of immunization. One of the qualities of the immunization program is an age-appropriate vaccine, it has become an ignored indicator of program performance. Even though age-appropriate vaccination is critical for child health, there are no national-level studies to generate conclusive and tangible evidence about the determination of timely vaccination in Ethiopia. OBJECTIVE: To assess the spatial pattern and associated factors of timely vaccination in Ethiopia using EDHS-2016 data: A multilevel and spatial analysis. METHOD: Community based cross-sectional study design was employed from 18 January to 27 June 2016. To select the participants, two-stage cluster sampling was employedin the Ethiopian Demographic Health Survey 2016 data. Permission was obtained via online request by explaining the aim of this particular study from DHS international. A statistical package for social science-21 software was used for data cleaning, recoding, and analysis. Arc GIS 10.3 software was used to show the spatial variation of age-appropriate vaccination practices. A generalized linear mixed-effect model was used. For all models, intra-class correlation, a proportional change in variance, the log-likelihood test, and the Akaike information criterion were calculated. The best model was selected by the lowest value Akaike information criterion. Variables with a p-value less than 0.05 and a 95% confidence level were considered for the statistically significant association. RESULT: The spatial distribution of age-appropriate vaccination practice in Ethiopia was non-randomly distributed with the global Moran's I value of 0.22 (p-value <0.001). The prevalence of age-appropriate vaccination practice in Ethiopia was 33.8%. Women who receive ≥ 2 TT vaccines (AOR = 1.48; 1.22, 1.79), women who lived in rural residences (AOR = 0.77; 0.62, 0.96), gave birth at a health facility (AOR = 1.2; 1.12, 1.37), ANC follow up (AOR = 174; 1.45, 2.1), richest (AOR = 1.65; 1.15, 2.37), richer (AOR = 1.72; 1.3, 2.22), middle-level income (AOR = 1.65; 1.16, 2.36), poorer (AOR = 1.47; 1.11, 1.96) were the factors of age-appropriate vaccination practice. CONCLUSION: The spatial distribution of age-appropriate vaccination practice in Ethiopia was non-randomly distributed across the regions. Age-appropriate vaccination practice was low in Ethiopia. Wealth index, usual caretaker of the child, ANC utilization, history of TT vaccination, place of delivery, and residence were associated with age-appropriate vaccination practice.


Subject(s)
Vaccination , Vaccines , Child , Humans , Female , Ethiopia/epidemiology , Cross-Sectional Studies , Health Surveys , Spatial Analysis , Multilevel Analysis
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