Pharmacy students' attitudes and intentions of pursuing postgraduate studies and training in pharmacogenomics and personalised medicine.

BACKGROUND: Pharmacists' contribution to pharmacogenomics (PGx) implementation in clinical practice is vital, but a great proportion of them are not aware of PGx and its applications. This highlights the university education's crucial role to prepare pharmacists to face future challenges in such a constantly evolving and demanding environment. OBJECTIVES: Our study aims to examine pharmacy students' training satisfaction, knowledge, self-confidence and attitudes towards PGx on their intentions for postgraduate training in PGx and personalised medicine (PM). METHODS: An initial model on students' intention to pursue postgraduate training in PGx and PM and its predicting factors, based on the Theory of Planned Behaviour (TPB), was proposed. Based on it, a questionnaire was developed and distributed to 346 pharmacy students of all study years, capturing the selected factors influencing students' intentions to postgraduate training in PGx and PM, as well as their demographics. Structural equation modelling (SEM) analysis was employed to determine the effects of both the examined factors and demographics on students' intentions. RESULTS: Students did not consider themselves adequately prepared for using PGx in clinical practice. Their attitudes towards PGx implementation were the most important factor influencing their intentions to pursue postgraduate training in PGx and PM. Other factors such as self-confidence and training satisfaction also affected students' intentions, but to a lower extent. Students of the last two study years (40% of the whole sample) and male (36%) students stated to be less willing to pursue PGx-related studies in the future. Only 10% of the participants claimed to have undergone a recent PGx or genetic test, but this did not affect their intentions. CONCLUSION: There is an important gap in pharmacy school curriculum regarding PGx and PM training which coupled with the slow rate of PGx and PM implementation into clinical practice seems to restrain students' aspiration to further expand their knowledge and horizons in terms of PGx and PM.

Economic evaluation of pharmacogenomic-guided antiplatelet treatment in Spanish patients suffering from acute coronary syndrome participating in the U-PGx PREPARE study.

BACKGROUND: Cardiovascular diseases and especially Acute Coronary Syndrome (ACS) constitute a major health issue impacting millions of patients worldwide. Being a leading cause of death and hospital admissions in many European countries including Spain, it accounts for enormous amounts of healthcare expenditures for its management. Clopidogrel is one of the oldest antiplatelet medications used as standard of care in ACS. METHODS: In this study, we performed an economic evaluation study to estimate whether a genome-guided clopidogrel treatment is cost-effective compared to conventional one in a large cohort of 243 individuals of Spanish origin suffering from ACS and treated with clopidogrel. Data were derived from the U-PGx PREPARE clinical trial. Effectiveness was measured as survival of individuals while study data on safety and efficacy, as well as on resource utilization associated with each adverse drug reaction were used to measure costs to treat these adverse drug reactions. A generalized linear regression model was used to estimate cost differences for both study groups. RESULTS: Based on our findings, PGx-guided treatment group is cost-effective. PGx-guided treatment demonstrated to have 50% less hospital admissions, reduced emergency visits and almost 13% less ADRs compared to the non-PGx approach with mean QALY 1.07 (95% CI, 1.04-1.10) versus 1.06 (95% CI, 1.03-1.09) for the control group, while life years for both groups were 1.24 (95% CI, 1.20-1.26) and 1.23 (95% CI, 1.19-1.26), respectively. The mean total cost of PGx-guided treatment was 50% less expensive than conventional therapy with clopidogrel [€883 (95% UI, €316-€1582), compared to €1,755 (95% UI, €765-€2949)]. CONCLUSION: These findings suggest that PGx-guided clopidogrel treatment represents a cost-effective option for patients suffering from ACS in the Spanish healthcare setting.

Examining key factors impact on health science students' intentions to adopt genetic and pharmacogenomics testing: a comparative path analysis in two different healthcare settings.

BACKGROUND: There is an increasing interest worldwide in investigating healthcare stakeholders' perceptions and intentions to adopt pharmacogenomics (PGx) into clinical practice. However, the existing inquiries based on well-established theories and models that interpret their intentions to implement PGx are scarce. This study is the first that examines the impact of selected factors on health science students' intention to adopt genetic testing applications using the technology acceptance model while it compares two different cultural groups: Greeks (Europe; Christian) and Malays (Asia; Muslim). RESULTS: Malay students were more persuaded about benefits of genomics for drug management compared to their Greek counterparts. However, participants from both countries appear to be particularly convinced about the benefits of genomics on disease management. Moreover, students from both countries considered the potential misuse of genetic information by corporate or government bodies as their most important concern; Greek students appeared to be considerably less worried than Malay about other probable hazards such as the deficient protection of privacy and confidentiality, which could be attributed to their religious background. Participants from both samples expressed very positive attitudes towards genetic research and testing and their favourable intentions to adopt genetic testing for personal use. Exploratory factors analysis and path analysis yielded quite similar results for both samples. Path analysis revealed that the factors of attitudes, concerns, drug management benefits and disease management benefits significantly influenced students' intentions to adopt genetic testing for personal use, with attitudes being the most inspirational factor with rather high impact, while training did not seem to affect participant's intentions. The squared multiple correlation of both models was quite satisfactory reaching to 0.55 for the Malaysian sample. CONCLUSION: Similarities in the results of the two groups along with the relevant validity and reliability tests indicate that the proposed model is a good fit for future studies to interpret stakeholders' intentions to adopt genetic testing. Therefore, it can provide a promising and reliable basis for future model development to explain the relationships between intentions to adopt genetic testing and its predictors.

How Do Pharmacy Students Make Career Choices in Genomics? Gender and Other Key Determinants of Pharmacy Senior Students' Intentions to Pursue Postgraduate Training in Pharmacogenomics.

Pharmacists play a pivotal role in pharmacogenomic (PGx) implementation in clinical practice, and their university education is considered a strong driver in holding favorable intentions toward PGx adoption. Using a survey developed based on the Theory of Planned Behavior (TPB), this study aimed to evaluate the determinants of senior pharmacy students' intentions to pursue postgraduate training in PGx and personalized medicine (PM), and with an eye to propose interventions to inform pharmacy students' career choices in the field. Students manifested considerably favorable attitudes toward PGx clinical practice and had acquired a relatively satisfactory level of knowledge. However, they conceded of having a hardly moderate level of confidence in PGx clinical application, and claimed to be moderately satisfied with their PGx training. Interestingly, students alleged to have a relatively limited interest to pursue postgraduate training studies in PGx and PM. Gender was a key and significant demographic moderator of the students' intentions to pursue postgraduate training in PGx and PM. We found that the students' attitudes exerted a strong positive impact on intentions for future PGx training, while self-confidence and training satisfaction had a moderate positive effect, respectively. We propose a set of key interventions that include, inter alia, the update of existing pharmacy curricula and the promotion of interdisciplinary collaborations with other health professionals, to reinforce the pharmacists' role in PM and PGx implementation in clinical practice. To the best of our knowledge, this is the first study using the TPB to identify the role of certain factors such as gender, attitudes, self-confidence, and training satisfaction on the final-year pharmacy undergraduate students' intentions to pursue PGx-related postgraduate studies in the future.

Adverse events of acute nephrotoxicity reported to EudraVigilance and VAERS after COVID-19 vaccination.

OBJECTIVES: The present study aimed to estimate the reporting rates (RRs) of acute kidney injury (AKI) and renal failure (RF) after COVID-19 vaccination in the European Economic Area (EEA) and the United States. METHODS: We retrieved and analyzed pharmacovigilance data on suspected AKI and RF cases and fatalities post COVID-19 vaccination with licensed vaccines reported to EudraVigilance and VAERS between week 52/2020 and week 52/2022 or week 1/2023, respectively. Reporting rates with 95% confidence intervals were estimated per million administered vaccine doses. RESULTS: In total, 4,244 AKI and 1,557 RF suspected cases were notified to EudraVigilance (1,692 AKI/971 RF) and VAERS (2,552 AKI/586 RF) during the study period following the administration of >1.6 billion COVID-19 vaccine doses (EEA: 970,934,453/US: 666,511,603). The overall RRs were 3.03 (95 % CI: 2.94-3.12) for AKI and 1.11 (95 % CI: 1.06-1.17) for RF per million administered vaccine doses. Indices for statistically significant increased risks were found in subjects, especially males, ≥65 years compared to 18-64 years old (AKI: OR = 7.23, 95 % CI: 6.63-7.88, p = 0.000, and RF: OR = 4.74, 95 % CI: 3.99-5.63, p < 0.001). AKI reporting rates were higher in the US, while RF reporting rates were higher in Europe. Both potential side effects were elevated following vectored rather than mRNA vaccines, with the highest reporting rates post AD26.COV2.S vaccination in the US (AKI: RR = 12.24, 95 % CI: 10.66-13.81; RF: RR = 3.17, 95 % CI: 2.36-3.97). There were 1,312 deaths possibly associated with AKI (RR = 0.94, 95 % CI: 0.89-0.99) and 460 deaths possibly associated with RF (RR = 0.33, 95 % CI: 0.30-0.36) per million vaccine doses. Fatalities were lower in Europe than in the US (AKI: OR = 0.25, 95 % CI: 0.22-0.28, p < 0.001; RF: OR = 0.82, 95 % CI: 0.69-0.99, p = 0.036). CONCLUSIONS: AKI and RF may be observed rarely following vaccination against COVID-19. Further studies are warranted to confirm these findings and uncover the underlying pathophysiological mechanism.

Anaphylaxis rates following mRNA COVID-19 vaccination in children and adolescents: Analysis of data reported to EudraVigilance.

AIM: The present study aimed to estimate the anaphylaxis rates following mRNA COVID-19 vaccination in children and adolescents in Europe. METHODS: We retrieved data on 371 anaphylaxis cases following mRNA COVID-19 vaccination in children ≤ 17 years old notified to EudraVigilance as of October 8, 2022. Overall, 27,120,512 doses of BNT162b2 vaccine and 1,400,300 doses of mRNA-1273 vaccine have been delivered to children during the study period. RESULTS: The overall mean anaphylaxis rate was 12.81 [95% confidence interval (CI): 11.49-14.12] per 106 mRNA vaccine doses [12.14 (95% CI: 6.37-17.91) per 106 doses for mRNA-1273 and 12.84 (95% CI: 11.49-14.19) per 106 doses for BNT162b2]. Children 12-17 years old accounted for 317 anaphylaxis cases, followed by 48 cases in children 3-11 years old, and 6 cases in children 0-2 years old. Children 10-17 years old had a mean anaphylaxis rate of 13.52 (95% CI: 12.03-15.00) cases per 106 mRNA vaccine doses and children 5-9 years old had a mean anaphylaxis rate of 9.51 (95% CI: 6.82-12.20) cases per 106 mRNA vaccine doses. There were two fatalities, both in the 12-17 years age group. The fatal anaphylaxis rate was 0.07 cases per 106 mRNA vaccine doses. CONCLUSIONS: Anaphylaxis is a rare adverse event after receiving an mRNA COVID-19 vaccine in children. Continuous surveillance of serious adverse events is needed to guide vaccination policies as we move towards SARS-CoV-2 endemicity. Larger real-world studies on COVID-19 vaccination in children, using clinical case confirmation, are imperative.

Anaphylactic Reactions to COVID-19 Vaccines: An Updated Assessment Based on Pharmacovigilance Data.

This study aimed at producing an updated assessment of the incidence of anaphylaxis associated with COVID-19 vaccines based on pharmacovigilance data. Anaphylactic reaction and anaphylactic shock data post-COVID-19-vaccination reported from week 52, 2020 to week 1 or week 2, 2023 were collected from the VAERS and EudraVigilance databases, respectively, and analyzed comparatively. Incidence rates were calculated using the corresponding administered vaccine doses as denominators for all licensed vaccines and both platform types (mRNA or vectored). The latest data from the present analysis showed lower anaphylaxis incidence associated with COVID-19 vaccination compared to previous estimates from week 52, 2020 to week 39, 2021 (anaphylactic reaction: 8.96 (95% CI 8.80-9.11)/million doses overall (EEA: 14.19 (95% CI 13.92-14.47)/million/US: 3.17 (95% CI 3.03-3.31)/million); anaphylactic shock: 1.46 (95% CI 1.39-1.52)/million doses overall (EEA: 2.47 (95% CI 2.36-2.58)/million/US: 0.33 (95% CI 0.29-0.38)/million)). Incidence rates varied by vaccine and were higher as captured in EudraVigilance compared to the VAERS and for vectored compared to mRNA vaccines. Most reported cases had a favorable outcome. The extremely rare fatalities (overall rates across continents 0.04 (95% CI 0.03-0.06)/million doses for anaphylactic reaction and 0.02 (95% CI 0.01-0.03)/million vaccine doses for anaphylactic shock) were also associated with vector-rather than mRNA-based vaccines. The diminished incidence of anaphylaxis post-vaccination with COVID-19 vaccines offers assurance about their safety, as does the continuous potential adverse events monitoring through specialized pharmacovigilance databases.

Comparative assessment of myocarditis and pericarditis reporting rates related to mRNA COVID-19 vaccines in Europe and the United States.

OBJECTIVES: The novel mRNA vaccines proved to be safe and effective in averting severe COVID-19. Vaccine-related complications recorded by pharmacovigilance systems, such as 'EudraVigilance' in Europe and 'VAERS' in the United States (US), rarely include myocarditis and pericarditis. Given the novelty of the platform and the increasing global-scale vaccine production needs, we assessed their reporting rates comparatively across continents. METHODS: Data of myocarditis and pericarditis cases post COVID-19 vaccination reported from week 52/2020 (December 21 to 27, 2020) to week 40/2021 (October 4 to 10, 2021) were collected for mRNA vaccines from EudraVigilance and VAERS. The corresponding administered vaccine doses were used as denominators to estimate reporting rates for comparison purposes. Cross-tabulation analysis was employed to compare the reporting rates of mRNA vaccines-associated myocarditis and pericarditis between EudraVigilance and VAERS. RESULTS: Low reporting rates of myocarditis (7.64/million vaccine doses) and pericarditis (5.32/million) were found, with higher rates of both disorders in EudraVigilance compared to VAERS; these differences were more pronounced post-mRNA-1273 (5-6-fold, p=0.000 for myocarditis and p<0.001 for pericarditis) than post-BNT162b2 vaccination (1.5-2-fold, p<0.001 for both conditions). Most myocarditis cases occurred in males <30 years. Pericarditis affected predominantly males <40 and both sexes >40 years. The extremely rare fatalities related to myocarditis (0.102/million) or pericarditis (0.017/million) were also higher in EudraVigilance versus VAERS. CONCLUSIONS: Understanding the underlying causes of the observed differences could provide guidance for the enhanced quality of mRNA vaccines that would also foster vaccine acceptance.

Adoption of Pharmacogenomic Testing: A Marketing Perspective.

Pharmacogenomics is becoming an important part of clinical practice and it is considered one of the basic pillars of personalised medicine. However, the rate of pharmacogenomics adoption is still low in many healthcare systems, especially in low- or middle-income countries. The low level of awareness of healthcare specialists could be a potential reason due to which pharmacogenomics application is still in a premature stage but there are several other barriers that impede the aforementioned process, including the lack of the proper promotion of pharmacogenomic testing among interested stakeholders, such as healthcare professionals and biomedical scientists. In this study, we outline the available marketing theories and innovation that are applied to personalized medicine interventions that would catalyze the adoption of pharmacogenomic testing services in clinical practice. We also present the current ethical and legal framework about genomic data and propose ways to tackle the main concerns mentioned in the literature and to improve the marketing perspective of PGx.

What Do Students in Pharmacy and Medicine Think About Pharmacogenomics and Personalized Medicine Education? Awareness, Attitudes, and Perceptions in Malaysian Health Sciences.

This study reports on the attitudes and perceptions toward pharmacogenomics (PGx) and personalized medicine (PM) education among pharmacy and medical students in Malaysian health sciences. Importantly, the survey was developed through a codesign approach, with field pretesting/design with users before the actual survey, and based on collaboration between institutions in Greece and Malaysia. The study addressed eight key areas of interest to education in health sciences: (1) General awareness about genetics and PGx, (2) Attitude toward genetic testing usefulness, (3) Benefits of direct-to-consumer personal genome testing as a "diagnostic" tool, (4) Concerns (risks) about genetics, (5) Effectiveness of genetic testing in PM, (6) Benefits of PGx on disease management, (7) Benefits of PGx on drug management, and (8) Attitudes toward genetic testing public endorsement. We observed that Malaysian students appear aware of the term PGx, but there are areas of critical knowledge gap such as the need for greater familiarity with the concept of PGx implementation science, and the availability of genetic testing in clinical practice. This is one of the first studies on perceptions and attitudes toward PGx testing in Southeast Asia. The present findings provide a map of the views and perspectives of medicine and pharmacy students regarding PGx and implementation of PM in Malaysia and should assist toward facilitating the integration of genomics into the medical decision-making process. To this end, it is necessary to enhance collaboration between universities, health care institutions, and governing bodies to incorporate further training and additional education topics related to PGx and genetic testing. This is the first study that assesses the level of PGx and genomics knowledge of pharmacy and medicine students in Southeast Asia, Malaysia in particular, and thus paves the way to guide future global PGx implementation science.

Attitudes and Awareness Toward Pharmacogenomics and Personalized Medicine Adoption Among Health Sciences Trainees: Experience from Greece and Lessons for Europe.

The increasing incorporation of genomics in clinical practice underscores the need to improve genomics knowledge and familiarity among future health care providers. To this end, it is important to consider both the "push" and the "pull" factors that shape or determine the transition of new personalized medicine (PM) discoveries to clinical practice. One of the pull factors involves the attitudes, values, and education of the user communities such as patients, physicians, and scientists who are poised to use the PM diagnostics. Among the push factors are often health scientists who contribute to PM science and development efforts. Seen in this light, health sciences trainees represent both the push and pull factors, not to mention the next generation of stakeholders and innovation actors who will make PM a reality in mainstream medical practice in the future. Τhis study aimed at investigating and comparing awareness and attitudes (ethical and other) on pharmacogenomics (PGx) and PM adoption among undergraduate students from the school of health sciences and other students. A convenience sample was used in this survey in two groups of students: 205 students from the School of Health Sciences and 141 students from other schools (e.g., biology, computer engineering, and business administration) of the University of Patras, Greece, and mostly at undergraduate education level. We observed that despite the relatively low level of awareness about genetics, PGx, and relevant notions, both groups of students were very optimistic about the genetic testing usefulness and professed their positive anticipations about PGx on disease management. Thus, health sciences students and those in other faculties appeared to be avid proponents of genetics testing and in favor of public endorsement of the concepts of individually tailored medicine. This case study in Greece is one of the first studies on perceptions and attitudes toward PGx testing and PM in Southern Europe. Of importance, the study informs the prospects and challenges on the push and pull factors of PM innovation while offering potential lessons for future PM curriculum needs in health sciences in other countries in Europe.

Patients' perceptions of generic drugs in Greece.

UNLABELLED: The use of generic drugs is growing increasingly around the world and in Greece, in particular, in order to reduce pharmaceutical expenditure. However, patients' perceptions and attitudes about generics have only partially been studied so far in Greece. OBJECTIVE: This study aimed to examine the factors that influence the attitude of patients and consumers regarding generic drugs. METHODS: A questionnaire survey of 364 patients visiting a pharmacy was conducted. The questionnaire consisted of 29 questions, including questions regarding their knowledge about generics, the reasons for using them, their previous experience, their willingness for generic substitution, and the factors behind these choices. RESULTS: Nearly half of the participants in the survey know the term 'generic' and that it has a lower price compared to the brand name drug. Their views on safety and efficacy vary significantly and the main source of information on generics is the media and the internet. The lack of knowledge is the main barrier for attitudes of doctors. Health professionals play the most influential role for the substitution of a branded drug by a generic, followed by the cost of the generic. CONCLUSIONS: Almost half of the patients know about generic drugs, with their lower price being the most popular feature which most patients are familiar with. It seems that primarily the doctor and, subsequently the pharmacist play the most important role in a patient's decision to replace his/her medicine with a generic.