Pharmacist assessments and care to improve adult vaccination rates: A report from project IMPACT vaccine confidence.

BACKGROUND: Neglect of vaccination needs among adults results in a needless burden of hospitalization, suffering, and death. America's community pharmacists deliver a substantial portion of adult vaccinations, yet many Americans still have unmet vaccination needs. OBJECTIVES: This study evaluated rates of vaccine contraindications, acceptance, and willingness to be vaccinated among ambulatory adults. PRACTICE DESCRIPTION: This was a prospective, multisite, multistate, observational study conducted in three waves between October 2021 and August 2023. PRACTICE INNOVATION: Pharmacists conducted comprehensive vaccination need assessments. EVALUATION METHODS: The primary outcomes were numbers of vaccination needs per participant and vaccinations administered, scheduled, or declined. RESULTS: Pharmacists identified a mean of 1.8-2.2 unmet vaccination needs per adult assessed, more than in pilot studies. Participants had already received 61%-74% of vaccinations recommended for them hence 26%-39% of needs were unmet at baseline. The leading vaccination needs were COVID-19, influenza, zoster, tetanus-containing, and pneumococcal vaccines. From a baseline mean of 59.1% for these five vaccinations, pharmacists increased the mean percentage vaccinated to 73.2%. When an option for scheduling future vaccination was added to the process, declinations dropped from 46%-18%. CONCLUSION: This study provides insight into adult vaccine acceptance, willingness, and declination behaviors not described elsewhere. Offering options for future vaccination reduced declination rates. Pharmacists resolved substantial proportions of adult vaccination needs. The signal that apportioning adult vaccines needed, but not received on day of assessment, across several months could help resolve unmet vaccination needs warrants additional research, especially with the rising number of vaccines recommended for adults.

Women in pharmacy: Pearls of wisdom from the 2022 inductees and contemporary leaders.

In 2012, the American Pharmacists Association Foundation (APhAF) recognized 17 women and three organizations for their work as pioneers and leaders among female pharmacists. In 2022, the APhAF selected ten additional leaders among contemporary women in American pharmacy to be honored in the Women in Pharmacy Exhibit and Conference Room on the top floor of the American Pharmacists Association (APhA) headquarters building in Washington, D.C. These ten leaders gathered at a symposium in their honor in October 2022 at APhA headquarters. This paper summarizes the accomplishments of the ten contemporary women and documents their comments at the symposium, where they discussed their perspectives on practice innovation, entrepreneurship, leadership, philanthropy, community service, and mentorship.

Pharmacy on the front lines: A century of pandemic response in America.

The history of American pharmacy contributions to pandemic responses can be described for five pandemics: 1918 (influenza A/H1N1 virus), 1957-1958 (H2N2 virus), 1968 (H3N2 virus), 2009 (H1N1pdm09 virus), and 2019-2023 (syndrome coronavirus-2 virus). Using historical surveillance data and published literature, this article provides opportunities to reflect on how the pharmacy profession played a role in preparedness and response.

Essential services: Quantifying the contributions of America's pharmacists in COVID-19 clinical interventions.

BACKGROUND: As the COVID-19 pandemic spread across the United States, America's pharmacists and their teammates expanded their clinical services to help their communities from every practice setting: community and ambulatory care, inpatient, long-term care, academia, public health, and many others. OBJECTIVES: The objective of the study is to begin to quantify contributions of U.S. pharmacists in providing clinical interventions that mitigate and control the pandemic. These interventions span the gamut of diagnosis, prevention, treatment, and support, intervening patient by patient with vaccines, diagnostic tests, convalescent plasma, monoclonal antibodies, antiviral medications, and supportive therapies. METHODS: Review of published literature, relevant web pages, and queries to national and state professional pharmacy associations and government agencies. RESULTS: From February 2020 through September 2022, pharmacists and their teammates conducted >42 million COVID-19 tests, provided >270 million vaccinations (including 8.1 million COVID-19 vaccinations for long-term care residents) within community pharmacy programs alone, and provided >50 million influenza and other vaccinations per year. Pharmacists plausibly accounted for >50% of COVID-19 vaccinations in the United States. Pharmacists prescribed, dispensed, and administered an uncounted number of antibody products and antiviral medications, including care for 5.4 million inpatients and innumerable outpatients. Using conservative estimates, pandemic interventions by pharmacists and teammates averted >1 million deaths, >8 million hospitalizations, and $450 billion in health care costs. CONCLUSIONS: Pharmacists and their teammates contributed to America's health and recovery during the COVID-19 pandemic by providing >350 million clinical interventions to >150 million people in the form of testing, parenteral antibodies, vaccinations, antiviral therapies, and inpatient care. The number of lives touched and people cared for by pharmacists continues to rise.

Vaccine humanity.

Vaccines to help prevent COVID-19 disease have evoked myriad human emotions. Attitudes of the public toward vaccination can be grouped into hundreds of categories. Pharmacists need to recognize the many elements of what may be termed "vaccine humanity," a complex tangle of human responses. Vaccine humanity applies to all vaccines, not just COVID-19 vaccines. Many of the emotions (pro and con) exhibited toward COVID-19 vaccines were also expressed (pro and con) with Edward Jenner's smallpox vaccine in the 1800s. New disease, new vaccines, same humanity. Human behaviors to seek or decline vaccination typically pivot on several core elements: perceptions of susceptibility to disease, seriousness of the disease, benefits of vaccination, and barriers (e.g., safety concerns, distance, costs, uncertainty). The pharmacist who contributes the time to listen and explain--listen and explain--listen and explain performs a vital clinical service: enabling vaccinations that promote health and prevent disease.

Pneumococcal serotype diversity among adults in various countries, influenced by pediatric pneumococcal vaccination uptake.

Streptococcus pneumoniae serotypes differ in clinical manifestations among adults. Indirect effects of pediatric use of pneumococcal conjugate vaccines (PCVs) affect rates of adult serotype-specific invasive pneumococcal disease (IPD). To characterize PCV effect on adult serotype patterns, we reviewed the literature for differences in proportions and incidence matching the 23-valent pneumococcal polysaccharide vaccine (PPSV23) and 13-valent PCV within specified geographic and time conditions. For adult IPD serotype distribution before widespread pediatric PCV7 use, the median differential between the 23 and 13 serotypes was 16.3% in the core analysis. After pediatric PCV7 adoption, the median differential was 24.4% (P < .003).The median differential in IPD incidence among adults was 5.6 cases per 100 000 population before pediatric PCV7 use and 6.4 afterward (P = .52). The differential for the serotypes in alternate vaccines helps explain recent national recommendations for one or both vaccines in various populations. These differences may widen further, with more extensive pediatric uptake of higher-valence PCVs.

Vaccines against mpox: MVA-BN and LC16m8.

INTRODUCTION: Global outbreaks involving mpox clade IIb began in mid-2022. Today, clade IIb and clade I outbreaks continue. Reliable mpox vaccines can prevent serious mpox disease and death. AREAS COVERED: Globally, two vaccines hold mpox indications, regardless of mpox viral clade: MVA-BN (Bavarian Nordic) and LC16m8 (KM Biologics). This review summarizes the human and pivotal animal data establishing safety and efficacy for MVA-BN and LC16m8, including real-world evidence gathered during mpox outbreaks from 2022 through 2024. EXPERT OPINION: Some regulatory decisions for MVA-BN and LC16m8 followed pathways based on surrogate outcomes, including lethal-challenge studies in nonhuman primates, among other atypical aspects. Nonetheless, MVA-BN and LC16m8 hold unencumbered registration in multiple countries. Effectiveness of MVA-BN as primary preventive vaccination (PPV) in humans against clade IIb mpox is clear from real-world studies; effectiveness of LC16m8 against clade IIb is likely from surrogate endpoints. Effectiveness of MVA-BN and LC16m8 as PPV against more-lethal clade I is likely, based on animal-challenge studies with multiple orthopoxvirus species and other studies. Both vaccines have solid safety records. MVA-BN's replication incompetence favors adoption, whereas LC16m8 has more pediatric data. Additional real-world evidence, in additional geographic settings and special populations (e.g. pregnancy, immune suppression, atopic dermatitis), is needed.

Situation Mpox outbreaks spread globally in 2022, hospitalizing many people. Many recent mpox cases in Africa occur in children. Two vaccines, known as MVA-BN and LC16m8, can help prevent mpox.MVA-BN MVA-BN protects animals from lethal doses of mpox and similar viruses. During outbreaks, MVA-BN lowered the chance of mpox disease by 62% to 85%. In people already exposed to mpox, MVA-BN reduced disease risk by 20%. MVA-BN may help reduce how serious mpox cases are, even if this vaccine does not block infection fully. MVA-BN cannot grow inside the body, making it very safe, even in children. Side effects include pain, redness, swelling, and itching. Some people feel muscle pain, headache, fatigue, nausea, or chills after vaccination. Several million people have received MVA-BN so far, including thousands of people living with HIV.LC16m8 LC16m8 protects animals from lethal doses of mpox and similar viruses. There are not much data about LC16m8 used during mpox outbreaks. LC16m8 contains a weakened virus. Side effects include fever, fatigue, redness, swollen lymph nodes, and itching. Vaccine virus can spread to other parts of the body. Over 90,000 people have received LC16m8 so far. No significant safety signals were found after these doses, including 50,000 children. People who are immunosuppressed, have certain skin diseases, or are pregnant should not be given LC16m8.Mpox vaccine recommendations Health officials recommend mpox vaccine for people at risk, including children.

Global geotemporal distribution of chikungunya disease, 2011-2022.

BACKGROUND: Chikungunya virus is a mosquito-borne alphavirus, transmitted by Aedes mosquitoes. Humans serve as the primary reservoir. Chikungunya infections typically appear with an abrupt onset of fever, rash, and severe joint pain. Some 40% of cases develop chronic rheumatologic complications that can persist months to years. OBJECTIVES: To improve precision of risk characterization by analyzing cases of chikungunya by year and by country and depicting this geotemporal distribution in map form. METHOD: Chikungunya case counts by year were compiled from national or regional health authorities from 2011 to 2022. These data were augmented by published reviews plus the Program for Monitoring Emerging Diseases (ProMED). Country-level distribution was categorized into four groups based on recency and magnitude. Data for India were mapped on a per-state basis. RESULTS: The global map depicts distribution of chikungunya disease from 2011 through 2022. Most cases are reported in tropical and subtropical areas, but notable exceptions include the northern coast of the Mediterranean Sea. Countries of high recency and frequency include India, Brazil, Sudan, and Thailand. Countries with high frequency, but few cases reported in 2019-22 include many Latin American and Caribbean countries. Subnational foci are discussed in general and mapped for India. The range of Aedes mosquitoes is broader than the geography where chikungunya infection is typically diagnosed. CONCLUSIONS: These maps help identify geographical regions where residents or travelers are at greatest risk of chikungunya. Once vaccines are licensed to help prevent chikungunya, maps like these can help guide future vaccine decision-making.

Evaluating risk of bias using ROBINS-I tool in nonrandomized studies of adjuvanted influenza vaccine.

Seasonal variation in influenza vaccine effectiveness (VE) makes real-world evidence (RWE) useful in supplementing the clinical-evidence base from randomized clinical trials. Adjuvanted inactivated influenza vaccine (aIIV) VE has been evaluated in multiple nonrandomized RWE studies. A systematic literature review of RWE studies evaluating the absolute or relative VE of aIIV was conducted. Identified studies were assessed by evaluators for risk of bias (RoB) by means of the ROBINS-I (Reduction of Bias In Non-randomized Studies of Interventions) tool to inform evidence-based medicine deliberations. Differences in evaluator assessments were resolved by consensus. The literature review yielded 14 follow-up studies, seven test-negative case-control (TNCC) studies, five traditional case-control studies, and one cluster-randomized clinical trial. Most follow-up studies and three TNCC studies were judged at low RoB. Issues increasing RoB included inadequate control of confounding, selection of controls, and reliance on recall of vaccination. The concerns identified in any of the designs could be mitigated with straightforward revisions to design or implementation. 17 of 27 nonrandomized studies of adjuvanted influenza-vaccine effectiveness, some from each of four study designs, were judged at low risk of material bias. These studies merit credence in assessing aIIV effectiveness relative to other influenza vaccines.

Effect of an Innovative Immunization Practice Model to Improve Population Health: Results of the Project IMPACT Immunizations Scaled Demonstration.

Background: U.S. adult vaccination rates remain low. Community pharmacists have skills and opportunity to improve this shortcoming. This study sought to evaluate an innovative practice model on identification of unmet vaccination needs and their resolution. Methods: This prospective, multi-site, multi-state, observational study was conducted in 22 community pharmacy practices in Iowa and Washington. Adults receiving influenza vaccination, medication therapy review, prescriptions for diabetes or cardiovascular disease, or another clinical encounter with a participating pharmacist from December 2017 through November 2019 were included. Pharmacists reviewed vaccination forecasts generated by clinical decision support technology based on their state immunization information system (IIS) to identify unmet vaccination needs, educate patients, and improve vaccination rates. The primary outcomes were numbers of vaccination forecast reviews, patients educated, unmet vaccination needs identified and resolved, and vaccinations administered. Secondary outcomes included numbers of vaccination declinations; times a forecasted vaccine was not recommended because a contraindication was identified by the pharmacist; and times the patients declined a forecasted vaccine due to self-reported vaccination despite lack of documentation in the state IIS. Descriptive statistics were calculated. Results: Pharmacists reviewed vaccination forecasts for 6,234 patients. The vaccination forecasts predicted there were 11,789 vaccinations needed (1.9 per person). 6,405 of the 11,789 unmet vaccination needs (54.3%) were fulfilled during the study period, including 60% on the same day. Of the forecasted needs, 1,085 (9.2%) were found to be previously administered and 59 (0.5%) contraindicated. The remaining patients received information about their personal vaccination needs and recommendations to be vaccinated. Conclusion: Availability of vaccination histories during patient encounters allowed pharmacists to identify and resolve adult vaccination needs in independent and chain community practice settings.

Daily versus single-day offering of influenza vaccine in community pharmacies.

OBJECTIVE: To assess the cumulative number of influenza vaccinations delivered per pharmacy in relation to number of days of offering vaccination per season. METHODS: Automated records of pharmacies involved in a cohort study were queried for number of influenza vaccinations delivered in each of three influenza vaccination seasons between 1996 and 1998. Eleven pharmacies in Washington State were compared with 13 pharmacies in Oregon, contrasting years when nurses offered influenza vaccine 1 day per season with years when pharmacists offered influenza vaccine daily for several months. RESULTS: Pharmacies in which pharmacists offered influenza vaccination daily averaged 528 to 807 doses per pharmacy per season compared with 91 to 233 doses per pharmacy in seasons when nurses offered vaccination on a single day. CONCLUSION: Professionals dedicated to providing adult vaccination on any given day outperformed professionals who attended to both vaccination and other clinical duties, but the cumulative effect of offering vaccinations on multiple days can achieve a greater number of vaccinations over a several-month interval.

Vaccines: countering anthrax: vaccines and immunoglobulins.

Anthrax spores rank as the leading threat among bioweapons. This article reviews the accumulated evidence for immunization, either active or passive, to counter the malicious release of anthrax spores. The key protective factor in current anthrax vaccines for humans is a protein called protective antigen, which allows ingress of toxins into cells. The US vaccine is licensed to prevent anthrax, regardless of the route of exposure. Its dosing schedule is cumbersome and somewhat painful (shortcomings that may be resolved by ongoing clinical studies). It can be prescribed with the confidence commensurate with dozens of human safety studies and experience in 1.8 million recent vaccinees. For post-exposure prophylaxis, combining antibiotic prophylaxis and active immunization before illness onset may offer the best combination of prompt and sustained protection, especially for people who inhale large doses of spores. To treat anthrax infection, passive immunization using a polyclonal or monoclonal antibody product may offer important clinical benefit, especially if the anthrax bacteria are resistant to multiple antibiotics.

Streptococcus pneumoniae outbreaks and implications for transmission and control: a systematic review.

BACKGROUND: Streptococcus pneumoniae is capable of causing multiple infectious syndromes and occasionally causes outbreaks. The objective of this review is to update prior outbreak reviews, identify control measures, and comment on transmission. METHODS: We conducted a review of published S. pneumoniae outbreaks, defined as at least two linked cases of S. pneumoniae. RESULTS: A total of 98 articles (86 respiratory; 8 conjunctivitis; 2 otitis media; 1 surgical site; 1 multiple), detailing 94 unique outbreaks occurring between 1916 to 2017 were identified. Reported serotypes included 1, 2, 3, 4, 5, 7F, 8, 12F, 14, 20, and 23F, and serogroups 6, 9, 15, 19, 22. The median attack rate for pneumococcal outbreaks was 7.0% (Interquartile range: 2.4%, 13%). The median case-fatality ratio was 12.9% (interquartile range: 0%, 29.2%). Age groups most affected by outbreaks were older adults (60.3%) and young adults (34.2%). Outbreaks occurred in crowded settings, such as universities/schools/daycares, military barracks, hospital wards, and long-term care facilities. Of outbreaks that assessed vaccination coverage, low initial vaccination or revaccination coverage was common. Most (73.1%) of reported outbreaks reported non-susceptibility to at least one antibiotic, with non-susceptibility to penicillin (56.0%) and erythromycin (52.6%) being common. Evidence suggests transmission in outbreaks can occur through multiple modes, including carriers, infected individuals, or medical devices. Several cases developed disease shortly after exposure (< 72 h). Respiratory outbreaks used infection prevention (55.6%), prophylactic vaccination (63.5%), and prophylactic antibiotics (50.5%) to prevent future cases. PPSV23 covered all reported outbreak serotypes. PCV13 covered 10 of 16 serotypes. For conjunctival outbreaks, only infection prevention strategies were used. CONCLUSIONS: To prevent the initial occurrence of respiratory outbreaks, vaccination and revaccination is likely the best preventive measure. Once an outbreak occurs, vaccination and infection-prevention strategies should be utilized. Antibiotic prophylaxis may be considered for high-risk exposed individuals, but development of antibiotic resistance during outbreaks has been reported. The short period between initial exposure and development of disease indicates that pneumococcal colonization is not a prerequisite for pneumococcal respiratory infection.

Assessing the safety of anthrax immunization in US Army aircrew members via physical examination.

OBJECTIVE: Anthrax in weaponized form is the bioterrorism agent of most concern. Questions raised about the safety of the anthrax vaccine can be addressed by comparing immunized and unimmunized people in population-based studies. METHODS: A retrospective evaluation of data from periodic physical examinations collected on anthrax-immunized and -unimmunized US Army aircrew members between 1998 and 2005 was performed to evaluate the safety of anthrax immunization. Mean changes in variables found on physical examination and laboratory analysis were compared by use of t tests. Multiple linear regression predicted change in outcome from baseline characteristics. RESULTS: We compared 6,820 immunized subjects and 4,145 unimmunized controls based on US Army aircrew physical examination and screening laboratory tests. No association between anthrax immunization and a clinically relevant change in a tested physiologic parameter was detected. CONCLUSIONS: No attributable risk of anthrax immunization was observed in this group of Army aircrew members.

Pandemics, avian influenza A (H5N1), and a strategy for pharmacists.

Epidemics of influenza occur annually and account for more morbidity in the developed world than all other respiratory diseases combined. On average, 36,000 Americans die from influenza or its complications each year. Pandemics occur when influenza viruses undergo either antigenic drift or antigenic shift that results in a new viral strain that infects humans, when they are capable of sustained transmission from person-to-person, and when they are introduced in populations with little or no preexisting immunity. The influenza pandemic of 1918 caused an estimated 20-40 million deaths worldwide. An avian influenza A (H5N1) virus, currently circulating in Asia, has pandemic potential. However, no evidence currently exists that a pandemic is occurring. Pharmacists are uniquely positioned to initiate nearterm practice changes that may positively impact both seasonal and potential pandemic morbidity and mortality. Pharmacists must be immunization advocates and provide pharmaceutical care that includes evaluation of immunization status. Increasing immunization to prevent invasive pneumococcal disease, as well as seasonal influenza immunization, is encouraged. A pandemic vaccine represents the most effective strategy to mitigate the effects of a pandemic. Antiviral agents represent a treatment bridge until a pandemic-specific vaccine is available. The neuraminidase inhibitors oseltamivir and zanamivir are active against H5N1, although oseltamivir resistance has been reported. Advances in vaccine research, development, and production through the use of reverse-genetics systems represent the most effective technology to rapidly produce a pandemic influenza vaccine.

Analysis of cases reported as generalized vaccinia during the US military smallpox vaccination program, December 2002 to December 2004.

BACKGROUND: We evaluated military personnel who developed dermatologic reactions suggestive of generalized vaccinia (GV) after smallpox vaccination. METHODS: We conducted surveillance and retrospective analysis of cases from the Vaccine Adverse Event Reporting System (a passive reporting system managed by the Centers for Disease Control and Prevention), and the military's preventive medicine channels, vaccine healthcare centers, clinical laboratory network, dermatology clinics, and pathology departments from December 2002 to December 2004. RESULTS: Of 74 cases investigated in 753,226 vaccinations, 50 (67.6%) met the case definition of possible GV (rate 66/million), 95% confidence interval (49-88/million), consistent with historically reported rates. Cases of possible GV occurred more frequently in primary vaccinees (81/million) than in those revaccinated (32/million) (relative risk 2.6, 95% confidence interval 1.2-5.9, P = .013). None met the case definition of probable or confirmed GV, including 15 with virologically negative laboratory evaluations (eg, culture, skin biopsy, or polymerase chain reaction). LIMITATIONS: The methods of case collection and retrospective nature of this study are its limitations. The clinical diagnosis of possible GV was made on the basis of the authors' interpretation of clinical notes and adverse events submitted by more than 100 different providers. Only 15 of the 74 cases of possible GV had laboratory attempts for virological confirmation. CONCLUSION: GV is still a rarely reported complication of smallpox vaccination. True GV, strictly defined, may be even less common than previously reported. We named one self-limited dermatologic manifestation confused with GV "postvaccinial nonviral pustulosis." Properly screened individuals considering smallpox vaccination may be assured most exanthemata after vaccination are benign.

Trends in the Numbers of US Colleges of Pharmacy and Their Graduates, 1900 to 2014.

Objective. To describe the cumulative and contemporary numbers of colleges and schools of pharmacy between 1900 and 2014 based on membership in the American Association of Colleges of Pharmacy or its predecessor, the American Conference of Pharmaceutical Faculties, as well as the mean number of graduates among member schools each year. Methods. A review of published literature for numbers of schools and graduates was conducted and descriptive statistics were calculated. Results. The cumulative number of schools rose from 21 to 152 between those years. The peak contemporary number was 130 in 2014. Including satellite campuses with parallel curricula brings the contemporary total to 172. The smallest number of graduates per member school per year occurred in 1945 and 1946, with peaks in 1951, 1977, and 2013 (∼110 per school per year in the latter two peaks). Conclusions. The number of US pharmacy schools progressively rose between 1900 and 2014, with the fastest rate of growth occurring in 2014. The mean number of graduates per school per year rose or fell with influences such as the Great Depression, World War II, and the GI Bill.