Assessment Committee Research Articles

Ethnic bias and the hidden curriculum: The impact of routine inclusion of ethnicity in medical education assessment

Introduction: In 2012, the University of Otago Medical School in New Zealand amended high stakes examination questions to routinely include ethnicity. This policy change was prompted by the assessment committee, including the Māori subcommittee. This study aimed to examine the portrayal of Māori patients and to explore the impact of routine inclusion of ethnicity. Methods: A quantitative description of demographic variables of examination questions and responses (role-model answers, multiple-response preferred answer, guidelines for markers) from a pre policy (2009–2011), post policy (2012–2013) and follow-up period (2018–2019) was undertaken. A qualitative content analysis of Māori examination questions was conducted with consideration of trends over time. Results: The majority (98%) of examination questions did not report ethnicity prior to the 2012 policy, whereas around 80% of cases did post policy implementation. Three themes were identified: the non-adherent Māori patient, determinants of health and the patient assigned Māori ethnicity. Examination questions and responses that portrayed Māori as being non-adherent were more common prior to the implementation of the policy. Post policy, many questions did not require students to consider the relevance of ethnicity but presented an increase in social and cultural contextual information of the patient over time. Conclusion: Policy implementation by the assessment committee led to less racist stereotyping and “othering” of Māori patients and prompted further refinement of social and cultural determinants of health over time. Future recommendations include increasing representation of Māori as a reflection of the increased burden of disease alongside representing intersectionality using other socio-cultural indicators.

Pseudoephedrine-Induced Risks of Posterior Reversible Encephalopathy Syndrome and Reversible Cerebral Vasoconstriction Syndrome

Abstract Background Pseudoephedrine is a sympathomimetic drug used as a nasal/sinus decongestant in common cold remedies. Objective The purpose of this review article is to discuss the pseudoephedrine-associated posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), which have been reported to the Medicines and Healthcare products Regulatory Agency (MHRA) of United Kingdom and Pharmacovigilance Risk Assessment Committee (PRAC) and Committee for Medicinal Products for Human Use (CHMP) of European Medicines Agency (EMA). Methods The aim is to review the literature pertinent to PRES and RCVS linked to the use of pseudoephedrine; the literature was searched in databases such as Medline/PubMed/PMC, Google Scholar, Science Direct, Ebsco, Scopus, Web of Science, Embase, and reference lists. Results The review by MHRA of the United Kingdom and PRAC and CHMP of EMA, all available evidence, including postmarketing safety data, and a few case reports, have confirmed the rare risk of PRES and RCVS associated with the use of pseudoephedrine. Conclusion Health care professionals should be aware of pseudoephedrine-associated PRES and RCVS. Patients with severe or uncontrolled hypertension or those with severe acute or chronic renal disease should avoid using products containing pseudoephedrine.

Assessing Radiology and Radiation Therapy Needs for Cancer Care in Low-and-Middle-Income Countries: Insight From a Global Survey of Departmental and Institutional Leaders

BackgroundThe global cancer burden and mortality rates are increasing, with significant disparities in access to care in low-and-middle-income countries (LMICs). This study aims to identify radiology and radiotherapy needs in LMICs from the perspective of departmental and institutional leaders. MethodsA survey was developed and conducted by the American Association of Physicists in Medicine (AAPM) Global Needs Assessment Committee (GNAC) and the AAPM International Council. The survey, organized into five sections (Introduction, Infrastructure Needs, Education Needs, Research Needs, and General Information), was open to respondents from March 1 to August 16, 2022. FindingsA total of 175 responses were received from six global regions: Africa (31.4%), Americas (17.7%), Eastern Mediterranean (14.3%), Europe (9.1%), South-East Asia (23.4%) and Western Pacific (4.0%). The greatest reported need was for new or updated equipment, particularly PET/CT imaging technology. There was also a high demand for clinical and equipment training. Approximately 25% of institutions reported a lack of radiology-based cancer screening programs due to high healthcare costs and a shortage of specialized equipment. Many institutions that expressed interest in research face funding and grant challenges. InterpretationThe findings highlight critical areas where organizations can support LMICs in enhancing radiology and radiotherapy services to mitigate the growing cancer burden.

Prompt Pattern Engineering for Test Question Mapping Using ChatGPT: A Cross-Sectional Study

ObjectiveThis study aimed to develop a prompt engineering procedure for test question mapping and then determine the effectiveness of test question mapping using Chat Generative Pre-Trained Transformer (ChatGPT) compared to human faculty mapping. MethodsWe conducted a cross-sectional study to compare ChatGPT and human mapping using a sample of 139 test questions from modules within the Integrated Pharmacotherapeutics course series. The test questions were mapped by 3 faculty members to both module objectives and the Accreditation Council for Pharmacy Education Standards 2016 (Standards 2016) to create the “correct answer”. Prompt engineering procedures were created to facilitate mapping with ChatGPT, and ChatGPT mapping results were compared with human mapping. ResultsChatGPT mapped test questions directly to the “correct answer” based on human consensus in 68.0% of cases, and the program matched with at least one individual human response in another 20.1% of cases for a total of 88.1% agreement with human mappers. When humans fully agreed with the mapping decision, ChatGPT was more likely to map correctly. ConclusionThis study presents a practical use case with prompt engineering tailored for college assessment or curriculum committees to facilitate efficient test questions and educational outcomes mapping.

Studying the Impact of European Union Regulatory Interventions for Minimising Risks From Medicines: Lessons Learnt and Recommendations.

The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) launched a strategy to examine the public health impact of major regulatory interventions aimed at minimising risks of medicinal products. We conducted a lessons learnt analysis of impact studies completed between 2015 and 2023. We surveyed PRAC Sponsors and (Co-)Rapporteurs involved in the evaluation of 12 impact studies (10 commissioned by EMA and 2 conducted collaboratively by Member States) to explore how these support regulatory decision-making. Questions covered achievement of study objectives, risk minimisation effectiveness, added value for regulatory decision-making, and recommendations for future impact studies. Themes were generated using thematic content analysis. Survey responses from 15 PRAC Sponsors and (Co-)Rapporteurs from 10 European Union Member States were included in the analysis. Among four cross-sectional surveys and eight drug utilisation studies, 50% achieved all objectives, the other studies partially due to limitations. Two studies concluded that risk minimisation measures were overall effective, two were effective with variation across countries, two were partially effective and four studies showed limited effectiveness. Two studies were deemed inconclusive due to limitations. The reasons for the limited effectiveness of risk minimisation may be explored using mixed-method approaches. Assessment of study feasibility and a priori discussion of effectiveness measurements is important. Despite limitations, impact research adds value to regulatory decision-making by addressing knowledge gaps and providing additional information on unintended consequences of regulatory interventions. Our recommendations will help to improve planning, conducting and interpretating future impact studies.

Limitations Reported in Evaluating Effectiveness of Risk Minimization Measures in the EU during 2018-2021: A Qualitative Analysis of Industry-Sponsored Post-Authorization Safety Studies.

Marketing-authorization holders evaluate the effectiveness of risk minimization measures (RMM) for medicines through the conduct of post-authorization safety studies (PASS). Earlier studies show that concluding on RMM effectiveness is challenging. The aim of this study was to describe reported limitations associated with RMM effectiveness assessments of industry-sponsored PASS that did not render a conclusion. We conducted a thematic analysis of study limitations extracted from assessment reports and study reports finalized by the Pharmacovigilance Risk Assessment Committee between 2018 and 2021. In 39 (61.0%) of the PASS a conclusion on RMM effectiveness was drawn, where 25 (39.0%) PASS was inconclusive. Most PASS had a cross-sectional design with surveys as primary data sources (73.4% and 65.6% respectively). Four main themes emerged: (i) survey-specific limitations, (ii) limitations specifically related to secondary use of data, (iii) general limitations related to study design, and (iv) limitations not related to study design. In general, frequently reported limitations were survey-related, such as selection bias or information bias. Interestingly, well-known study limitations related to secondary use of data such as missing or misclassification of data were more often presented in inconclusive compared with conclusive PASS. Given that about 40% of PASS did not allow a conclusion on RMM effectiveness, our results suggest prioritization for strategies to mitigate limitations related to the secondary use of data at the protocol stage, for example, through feasibility assessments. Although many databases may have incomplete registration of some variables, feasibility testing prior to conducting a PASS could contribute to meeting study objectives and concluding on RMM effectiveness.

Hitting two birds with one stone: DPAC derivatization with o-carborane resulted in improved photochemical stability and enhanced sensing performance

Innovative design of sensing materials is pivotal for the development of high-performance fluorescence film sensors (FFSs). In this work, we combined one or two o-carboranyl units into the skeleton of N,N′-diphenyldihydrodibenzo[a,c]phenazine (DPAC), a well-known fluorophore, and obtained two new DPAC derivatives, CbDPAC-Ph and bis-CbDPAC-Ph. We found incorporation of o-carborane not only enriches the stacking of DPAC, enhancing photostability and increasing the Stokes shift, but also facilitates analyte mass transfer in the fluorescent active layer due to increased molecular channels. Further studies revealed that the FFSs based on bis-CbDPAC-Ph exhibit outstanding cyclic stability and are highly sensitive to acrylonitrile (ACN), with a detection limit of 22 ppb, significantly lower than the 450-ppb threshold value recommended by the Risk Assessment Committee (RAC) of Europe for workplaces. Moreover, with a response time within 2 s and a full recovery time of less than 2 min, this device shows promising potential for developing into a portable ACN detector.

장기요양등급판정 신청 후 그 판정 전 피보험자 사망 시 요양진단비 보험금 지급 여부 - 대법원 2023. 10. 12. 선고 2020다232709, 232716 판결

The first trial ruling said, “in this case, the meaning of the occurrence of an insured event(rating determination) that occurred during the insurance period specified in the insurance contract is sufficient if it is confirmed that the fact that causes the rating determination, that is, the health condition is sufficient to require long-term care, and the rating “just because the date of judgment is after death cannot be viewed differently.” The lower court ruling cited the first trial ruling. However, the supreme court ruling is, as a reason for payment of insured amount stipulated in the insurance contract in this case, unless there are special circumstances such as if the insured is recognized as eligible for long-term care insurance for the elderly during the insurance period, the insured is subject to a rating by the assessment committee during the insurance period. This refers to cases where a long-term care grade has been determined by the committee. As seen above, i agree with the supreme court ruling. However, since there are contents that were not covered in the supreme court ruling, the lower court ruling, or first trial ruling, this article additionally reviewed the above contents. Through this article, i hope to resolve questions regarding issues related to ‘whether or not application for assessment for long-term care fee will be paid when the insured dies after applying for assessment for long-term care but before the assessment is made.’

간병보험 약관의 ‘보험기간 중 보험사고 발생’ 조항에 대한 해석론 - 대법원 2023. 10. 12. 선고 2020다232709, 232716 판결의 평석

The Supreme Court recently rendered a decision on the interpretation of the “occurrence of an insured event during the insurance period” clause in the terms and conditions of long-term care insurance. In this decision, the Supreme Court applied various rules of standard form contract interpretation to lay out a detailed theory of interpretation. As the insurer's liability to pay insurance benefits arises only if the insured event specified in the insurance contract occurs during the insurance period, the determination of whether the insurer’s liability has arisen must be preceded by the interpretation of the “occurrence of an insured event during the insurance period” clause in the insurance terms and conditions that constitute part of the insurance contract. If one finds the grounds for which insurance terms and conditions are binding on the contracting parties in the parties’ mutual agreement, the general principles of legal acts, i.e., contracts, interpretation are applicable to the interpretation of insurance terms and conditions. Additionally, the various rules of standard form contract interpretation specifically provided for in the Act on the Regulation of Terms and Conditions are also applicable. In the case addressed by this article, the Supreme Court’s interpretation of the disputed clause in the long-term care insurance terms and conditions differed from that of the lower and appellate courts. The Supreme Court, adhering to principles of contract interpretation, focused on the wording of the clause in question while also considering the context, including the purpose and intent of long-term care insurance, trade practices and other relevant factors. The Supreme Court further applied the principle of objective interpretation, rooted in the principle of good faith as stipulated in the Act on the Regulation of Terms and Conditions. Consequently, the Supreme Court interpreted the clause stating insurance benefits are payable “if the insured is recognized as eligible for long-term care insurance benefits during the insurance period” to mean that insurance benefits are payable “if the insured receives a long-term care rating from the assessment committee during the insurance period,” in accordance with the wording of the clause. Furthermore, the Supreme Court determined that this interpretation did not violate the principle of good faith beyond the limits of private autonomy, thus ruling out the complete nullification or partial nullification, i.e., validity-preserving interpretative reduction, of the clause. Based on this interpretation, the Supreme Court ruled that if the insured was assessed with a long-term care rating after the insurance period terminated due to the insured’s death, the insured event could not be considered to have occurred during the insurance period, even if it was confirmed that the insured was in a state requiring long-term care during the insurance period, and therefore, the insurer's liability to pay insurance benefits did not arise. This court decision is significant as it is the first to establish a specific interpretation theory for the “occurrence of an insured event during the insurance period” clause in long-term care insurance policies. Given that many long-term care insurance products currently on the market have clauses with similar structures and content, the standards and interpretation methods from this decision are expected to apply to future disputes relating to the insurer's liability to pay insurance benefits under such contracts. Moreover, the court decision is meaningful in that it clearly delineates the limits of validity-preserving interpretative reduction or modifying interpretation.

Prevalence of Adverse Drug Reactions in Diabetic patients receiving Antidiabetic Medications at Tertiary Care Hospital

Background: Diabetes mellitus is a chronic metabolic condition defined by elevated blood glucose levels caused by abnormalities in insulin secretion, insulin action, or both. Anti-diabetic drug pharmacovigilance can be extremely useful in identifying and resolving the adverse drug reactions (ADRs) and safeguarding patients from needless injury. Objective: The objective of the study was to determine the prevalence of various adverse events caused by the use of anti-diabetic medications in patients treated at tertiary care hospital. Method: It was a randomized controlled study where the participants were randomized into two groups i.e., interventional or study group and control group. All suspected ADRs were collected, analysed and confirmed by the physician-in-charge and were assessed for causality using WHO-UMC Causality Categories, Naranjo’s causality assessment scale, preventability using Modified-Schumock and Thornton scale, severity using Modified Hartwig and Siegel scale by the Causality Assessment Committee (CAC). Results: The study included a total of 300 subjects among which 218 were male (72.67%) and 82 were female (27.33%). A total of 300 patients, 104 ADRs were identified, in which 46.15% were observed in the control group and 53.85% in the interventional group. Females were more prevalent to the ADRs. The majority of ADRs were seen in age group of >70 in which 15.38% were observed in the control group and 18.27% in the interventional group. The Highest observed ADR of 20 (19.23%) was Hypoglycemia in which 9(8.65) were observed in the control group and 11(10.57) in the interventional group followed by weight gain i.e, 10 (9.61%) in which 5(4.80%) were observed in the control group and 5(4.80%) in the interventional group. Conclusion: ADR relating to antidiabetic therapy utilizing oral antidiabetics and insulin was found to be prevalent. The doctors and clinical pharmacists are therefore needed to identify and report the appropriate signals generated to the nearest ADR monitoring centre or Pharmacovigilance Programme of India for the benefit of the patients.

Investigating the Relevance of the Development and Implementation of Strategic Plans in Public Sector Education Institutions: A Case of Public Teacher Training Colleges in Malawi

The hub of every academic institution of higher learning rests upon key areas of policies and how they are developed, managed and championed. This research study investigated the relevance of development and implementation of strategic plans in public sector education institutions in Malawi. In 2019 and 2020, GIZ championed the development of strategic plans in TTCs. This was done by facilitating the training of Principals in the quest to develop strategic plans. Field data was collected using both qualitative and quantitative approaches through document analysis, questionnaires, and focus group discussion guide. The findings of the study indicate that the strategic plans are relevant in public TTCs because of the following factors: government policy, strong committed leadership, organizational culture, structure and effective communication. The study findings support Bryant (2013) in his evaluation report in Malawi and the study by Nyakeriga (2015) who identified the same factors as influencing the development and implementation of strategic plans. The structure is identified by the setup of the public TTCs, with the principal being the top manager, followed by the Deputy Principal, Heads of Departments, Teaching Practice Coordinator, and Assessment Committee chairperson. through the organizational culture, Quality Assurance and Monitoring and Evaluation work to track the progress of the implementation process in the TTCs. The study also showed plans the activities in the strategic plan inform TTC budgets. However, the study has firmly established that completing the activities in the strategic plans is a challenge. The study attributes this to erratic and inadequate funding, lack of knowledge on the implementation process and lack of political will. The study proposes investment in continuous professional development with all education stakeholders to fully understand the concept of strategic planning and implementation in order to achieve set objectives.

Assessing the impact of authorisation process as a regulatory tool in the European REACH regulation: A study on improving occupational safety for applying companies.

This study looks into the effectiveness of the authorisation procedure as a regulatory instrument within the framework of the European REACH regulation. It highlights its impact on enhancing occupational safety and health for both applicants and companies utilising the substances. This procedure encompasses manufacturers, importers, and downstream users of substances, as well as representatives of foreign manufacturers who are also eligible to seek authorisation. When applying for authorisation, the ECHA Risk Assessment Committee (RAC) assesses the risks associated with the intended uses of the substance, including the appropriateness and effectiveness of the Occupational Conditions (OCs) and Risk Management Measures (RMMs) described in the application and the risks posed by potential alternatives. If the RAC determines that the OCs/RMMs are inadequate for managing or controlling the risk, or if the measures to protect workers are deemed insufficient, it may recommend additional measures to enhance occupational safety and health or environmental protection. The 398 processed Applications for Authorisation (AfA) that have been submitted to date were examined to determine these recommended measures, categorised as Conditions for use, Monitoring arrangements, and Recommendations for Review Reports. Overall, a significant improvement concerning occupational safety and health seems necessary, as indicated by the large number of measures recommended by the ECHA Committee for Risk Assessment (RAC) and ECHA Committee for Socio-economic Analysis (SEAC) or supplemented by the European Commission. In addition to the proposed measures, a short assessment provided by the committees as to whether the operational conditions and risk management measures are adequate in controlling the risks is also included in the study.

Costs and benefits in patients with NYHA class III heart failure treated with CardioMEMS in Italy.

CardioMEMS is a device suitable for telemedicine that is currently being evaluated by the Regional Health Technology Assessment (HTA) Committee of Tuscany. Two detailed HTA reports are available in the specialized literature, the results of which need to be transferred to our regional setting. These decisions in Tuscany are made by the so-called Centro Operativo HTA. To validate, with local cost-effectiveness data, the decision on CardioMEMS that will be made in the Tuscany region. Two detailed international HTA reports were rearranged and adapted to our regional setting to generate a simplified analysis that could form the basis of our decision. Two willingness-to-pay (WTP) thresholds of €20,000/quality-adjusted life year (QALY) and €50,000/QALY were considered. Based on epidemiological and regulatory information, the target population in Tuscany for this device is 166 cases. The value-based price of CardioMEMS is estimated to be €4,332 and €16,662 at WTP thresholds of 20,000/QALY and 50,000/QALY, respectively. Its current price in Italy is €12,000. In our region, the introduction of CardioMEMS is likely to be gradual, around 50 patients/year (or €0.60 million/year at current price). This example highlights the need to adapt the information published in the international literature to the local context in which the approval decision is made. In this context, simplified analyses are easier to apply than complex Markov models.

Physician Awareness of the Safe Use of Cyproterone Acetate in Europe: A Survey on the Effectiveness of Additional Risk Minimization Measures.

Cyproterone acetate (CPA) is a synthetic progesterone derivative introduced in the 1970s and prescribed as antiandrogenic therapy for inoperable prostate cancer, sexual deviations in men, and signs of androgenization in women. In 2020, the CPA summary of product characteristics (SmPC)was revised to include an updated special warning and precaution about (1) the risk of meningioma with increasing cumulative dose and (2) contraindication in patients with meningioma or history of meningioma. A Direct Healthcare Professional Communication(DHPC) was distributed. The European Medicine Agency's Pharmacovigilance Risk Assessment Committee requested that marketing authorization holders in Europe conduct a survey to assess physicians' knowledge of the updated key safety information. The primary objective of this study was to measure physicians' awareness (i.e., did they receive and review the revised SmPC and DHPC) and level of knowledge and understanding of the key safety information pertaining to the restricted use of CPA monotherapy because of the risk of meningioma. This cross-sectional web-based survey was administered to dermatologists, endocrinologists, gynecologists, urologists, oncologists, psychiatrists, and general practitioners in France, Germany, Poland, Spain, and the Netherlands who had prescribed CPA monotherapy in the previous 12 months to assess awareness of the risk of meningioma associated with CPA monotherapy. Of the 613 physicians who participated, 85% correctly indicated that CPA monotherapy should be prescribed with the lowest effective dose, 75% correctly indicated that the risk of meningioma increases with increasing cumulative CPA monotherapy doses, and 73% correctly indicated that treatment with CPA-containing products must be stopped permanently if a patient is diagnosed with meningioma. Overall, 40% of physicians reported having received the DHPC, and 42% reported having received the revised SmPC. Despite low recall of receipt of the updated SmPC and DHPC, most physicians surveyed are aware of the meningioma risk and actions to mitigate the risk.

Glucagon-like Peptide-1 Receptor Agonists and Suicidal Ideation: Analysis of Real-Word Data Collected in the European Pharmacovigilance Database.

A potential risk of suicide associated with liraglutide or semaglutide treatments has recently emerged. Therefore, we decided to investigate the reporting probability of suicidal events among glucagon-like peptide-1 receptor agonists (GLP-1 RAs). A retrospective pharmacovigilance study of the European Pharmacovigilance database was conducted for the period from 1 January 2018 to 10 July 2023. Disproportionality analyses (reporting odds ratio, ROR) were performed to assess the reporting probability of suicidal events among GLP-1 RAs. A total of 230 reports of suicidal events were identified. The most reported GLP-1 RA was liraglutide (38.3%), followed by semaglutide (36.5%) and dulaglutide (16.1%). The most reported events were suicidal ideation (65.3%) and suicide attempt (19.5%). Disproportionality analysis found a higher reporting probability of suicidal events for semaglutide than dulaglutide (ROR, 2.05; 95%CI, 1.40-3.01) and exenatide (ROR, 1.81; 95%CI, 1.08-3.05). In the same way, liraglutide was associated with a higher reporting probability of suicidal events than dulaglutide (ROR, 3.98; 95%CI, 2.73-5.82) and exenatide (ROR, 3.52; 95%CI, 2.10-5.92). On the contrary, a lower reporting probability was found for semaglutide than liraglutide (ROR, 0.51; 95%CI, 0.38-0.69). Suicidal events were mostly reported with semaglutide and liraglutide, which were also associated with significantly higher reporting probabilities compared to other GLP1 RAs. Although this study provides the reporting frequencies of suicide-related events with GLP-1 RAs, establishing causality requires further investigation, which will probably be addressed by the Pharmacovigilance Risk Assessment Committee of the European Medicine Agency in the future.

A Review of Current Approaches to Evaluating and Reimbursing New Medicines in a Subset of OECD Countries.

The aim of this study was to review the current evaluation and funding processes for new drugs in different developed countries, to provide a comparative framework with detailed, homogeneous, and up-to-date information. Scientific publications, reports and websites were reviewed between July and December 2021 using PubMed, Google Scholar, and grey literature sources. The main items searched were actors and processes, including timelines, characteristics of clinical and economic evaluations, participation of stakeholders, elements of price and reimbursement decisions, cost-effectiveness thresholds and specific funds. The analysed 13 countries were Australia, Canada, England, France, Germany, Italy, Japan, the Netherlands, Portugal, Scotland, South Korea, Spain and Sweden. Eight countries perform the assessment process separated from the pricing decision. Countries measure each drug's added therapeutic value through multi-attribute value scales, algorithms, non-prescriptive lists of criteria, or quality-adjusted life years (QALYs). Health technology assessment (HTA) methodologies differ in their outcome measures, elicitation techniques, comparators, and perspectives. The criteria used for pricing and reimbursement include humanistic, clinical, and economic aspects. Only Scotland, England, the Netherlands, Canada and Portugal use explicit efficiency thresholds. Health care professionals participate in all assessment committees, and patients are becoming increasingly involved in most countries. The official time from marketing authorisation to the completion of the evaluation and pricing processes varied from 126 to 540 days. Most analysed countries show a trend towards value-based approaches that consider value for money to society, but also other economic, clinical, and humanistic criteria. Good practices included robustness, transparency, independence, and participation.

Expert consensus on fundus photograph-based cardiovascular risk assessment using artificial intelligence technology

Cardiovascular risk assessment is a basic tenet of the prevention of cardiovascular disease. Conventional risk assessment models require measurements of blood pressure, blood lipids, and other health-related information prior to assessment of risk via regression models. Compared with traditional approaches, fundus photograph-based cardiovascular risk assessment using artificial intelligence (AI) technology is novel, and has the advantages of immediacy, non-invasiveness, easy performance, and low cost. The Health Risk Assessment and Control Committee of the Chinese Preventive Medicine Association, in collaboration with the Chinese Society of Cardiology and the Society of Health Examination, invited multi-disciplinary experts to form a panel to develop the present consensus, which includes relevant theories, progress in research, and requirements for AI model development, as well as applicable scenarios, applicable subjects, assessment processes, and other issues associated with applying AI technology to assess cardiovascular risk based on fundus photographs. A consensus was reached after multiple careful discussions on the relevant research, and the needs of the health management industry in China and abroad, in order to guide the development and promotion of this new technology.

Update on the efficiency and safety of orally administered nasal decongestants

Nasal congestion leading to obstruction is one of the main symptoms in acute rhinosinusitis (common cold), other upper respiratory infections and allergic rhinitis. The EPOS 2020 guidelines place oral decongestants as an efficient therapy for the relief of nasal obstruction. In Romania, there are more than 50 available nasal decongestants, so it is very important for practitioners from all medical domains to be aware of recent data regarding their effectiveness and safety profile. Recent concerns raised by both the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) regarding the efficacy and safety of pseudoephedrine (PSE) and phenylephrine (PHE) emphasize the need for informed decision-making in prescribing. Notably, there were concerns raised about the association between PSE, reversible cerebral vasoconstriction syndrome (RCVS) and posterior reversible encephalopathy syndrome (PRES). EMA’s safety committee, Pharmacovigilance Risk Assessment Committee (PRAC), recently recommended measures to minimize risks of serious side effects when using medicines containing PSE. PRAC recommends that medicines containing PSE should not be used in patients with severe or uncontrolled hypertension and severe acute or chronic kidney disease or failure. Additionally, PRAC recommends healthcare professionals to counsel patients to discontinue the use of such medicines promptly and seek medical assistance if they experience symptoms suggesting PRES or RCVS, such as sudden onset of severe headache, confusion, vomiting, visual disturbances or seizures. While effectiveness of oral PSE is confirmed by clinical studies, expert consensus is unfavorable to PHE. Both in vitro and in vivo clinical pharmacology data indicate that neither the recommended doses nor higher doses of oral PHE demonstrate efficacy in alleviating symptoms of nasal congestion.

Menstrual Irregularities Following Covid-19 Vaccinations

Since 31 December 2019, when the WHO was informed of cases of pneumonia of unknown cause in Wuhan City, China; a novel coronavirus identified as the cause, has spread worldwide. With an urgent need to slow viral transmission, decrease disease severity, and reduce mortality, biopharmaceutical companies rapidly began investigating potential COVID-19 vaccinations. The American pharmaceutical company, Pfizer, in collaboration with the German company, BioNTech, developed a nucleoside-modified messenger RNA (modRNA) vaccine (BNT162b2), which was the first to receive an FDA permit for emergency use, with others following suit. Vaccine manufacturers provide a list of post-vaccination side effects with their preparations. Adverse vaccine reactions are evidence of the effectiveness of the vaccine and of increasing immunity against this disease. Interestingly, a growing number of women have reported menstrual irregularities after receiving COVID-19 vaccines. Those have been noted in post-authorization and post-licensure monitoring. This review provides evidence that women experience menstrual abnormalities, including menorrhagia, metrorrhagia, and polymenorrhea following COVID-19 vaccines. The importance of the issue has been recognized by the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency which decided to list heavy menstrual bleeding as a side effect as a side effect of unknown frequency in the product information for the SARS-CoV-2 mRNA vaccines.

Enhancing Awareness of Diclofenac as an Over-the-Counter Analgesic in the Northern Border Region of Saudi Arabia

Introduction: Diclofenac was identified by the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency as a high-risk NSAID in terms of its effects on the heart and circulation when administered systemically, i.e. capsules, tablets or injections.
 Objective: To evaluate the knowledge and awareness about over the counter analgesic medication (Diclofenac) among people living in northern border region – Saudi Arabia.
 Methodology: Self-administered cross-sectional study conducted during a period of two months (October and November 2023) on random sample of 430 Saudi people living in the Northern Border Region. The data was analyzed by Microsoft excel program by means of Descriptive statistics.
 Results: Toothache and headache were the most worried pain among participants (32%) and (31%) respectively, majority (72%) of participants buy OTC medication for pain from community pharmacy on the advice of pharmacist. Small percentage (20%) thought that medications containing diclofenac have very few side effects, 76% didn’t know any side effect of diclofenac, 47% didn’t know that diclofenac in high dose has adverse effects on kidney, 71% didn’t know that diclofenac cause gastrointestinal adverse effects. About one fifth of participants (21%) didn’t know the maximum dose of diclofenac when they use it, tablet is the preferred dosage form of diclofenac (27%) followed by granules (16%), dosage of 100 mg is the most frequently used (36%) followed by 50 mg (16%). 
 Conclusion: Saudi people’s knowledge about diclofenac as one member of non-steroidal anti-inflammatory drugs was insufficient. Knowledge about related adverse effects of diclofenac was lacked which exposes to misusage that may carry accidents and severe side effects especially among high-risk population.