Redefining the Role of Medical Affairs Professionals as Innovators and Leaders in Industry-Led Medical Education.

Medical affairs professionals are pivotal players at the intersection of medical innovation and practice in the pharmaceutical industry. They are uniquely positioned to translate complex medical knowledge into actionable insights for internal and external stakeholders. Industry-led continuing medical education (CME) programs, guided by these professionals, hold the potential to markedly improve clinicians' application of evidence-based medicine (EBM) in clinical settings, thereby elevating patient care outcomes. However, current CME techniques often overlook the integration of diverse disciplines such as educational theories, cognitive psychology, information mastery, and implementation science, which are important for effective real-time decision-making in patient care. This gap in integrating implementation science is vital, as it is key in ensuring that medical innovations are not just developed but also effectively implemented and efficiently utilized in clinical settings. In this opinion article, we aim to highlight the crucial yet often underrecognized role of medical affairs professionals in shaping robust and practical CME programs within the industry. We explore emerging trends and approaches in medical education and CME based on the principles of adult education. Additionally, we explore how medical affairs professionals can effectively drive the adoption of EBM in clinical practice. This exploration aims to provide insights into enhancing CME programs, with medical affairs professionals at the forefront of innovation and leadership in bridging gaps in clinical practice.

Modelling the Potential Public Health Impact of Different COVID-19 Vaccination Strategies with an Adapted Vaccine in Singapore.

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causing COVID-19 has been a dynamically changing virus, requiring the development of adapted vaccines. This study estimated the potential public health impact alternative vaccination strategies for COVID-19 in Singapore. RESEARCH DESIGN AND METHODS: The outcomes of alternative vaccination strategies with a future adapted vaccine were estimated using a combined Markov decision tree model. The population was stratified by high- and standard-risk. Using age-specific inputs informed by local surveillance data and published sources, the model estimated health (case numbers, hospitalizations, and deaths) and economic (medical costs and productivity losses) outcomes in different age and risk subpopulations. RESULTS: Booster vaccination in only the elderly and high-risk subpopulation was estimated to avert 278,614 cases 21,558 hospitalizations, 239 deaths, Singapore dollars (SGD) 277 million in direct medical costs, and SGD 684 million in indirect medical costs. These benefits increased as vaccination was expanded to other subpopulations. Increasing the booster vaccination coverage to 75% of the standard-risk population averted more deaths (3%), hospitalizations (29%), infections (145%), direct costs (90%), and indirect costs (192%) compared to the base case. CONCLUSIONS: Broader vaccination strategies using an adapted booster vaccine could have substantial public health and economic impact in Singapore.

Modelling the potential public health impact of different vaccination strategies with an omicron-adapted bivalent vaccine in Thailand.

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causing COVID-19 has continuously evolved, requiring the development of adapted vaccines. This study estimated the impact of the introduction and increased coverage of an Omicron-adapted bivalent booster vaccine in Thailand. RESEARCH DESIGN AND METHODS: The outcomes of booster vaccination with an Omicron-adapted bivalent vaccine versus no booster vaccination were estimated using a combined cohort Markov decision tree model. The population was stratified into high- and standard-risk subpopulations. Using age-specific inputs informed by published sources, the model estimated health (case numbers, hospitalizations, and deaths) and economic (medical costs and productivity losses) outcomes in different age and risk subpopulations. RESULTS: Booster vaccination in only the elderly and high-risk subpopulation was estimated to avert 97,596 cases 36,578 hospitalizations, 903 deaths, THB 3,119 million in direct medical costs, and THB 10,589 million in indirect medical costs. These benefits increased as vaccination was expanded to other subpopulations. Increasing the booster vaccination coverage to 75% of the standard-risk population averted more deaths (95%), hospitalizations (512%), infections (782%), direct costs (550%), and indirect costs (687%) compared to the base case. CONCLUSIONS: Broader vaccination with an Omicron-adapted bivalent booster vaccine could have significant public health and economic benefits in Thailand.

Impact of vaccination and non-pharmacological interventions on COVID-19: a review of simulation modeling studies in Asia.

Introduction: Epidemiological modeling is widely used to offer insights into the COVID-19 pandemic situation in Asia. We reviewed published computational (mathematical/simulation) models conducted in Asia that assessed impacts of pharmacological and non-pharmacological interventions against COVID-19 and their implications for vaccination strategy. Methods: A search of the PubMed database for peer-reviewed, published, and accessible articles in English was performed up to November 2022 to capture studies in Asian populations based on computational modeling of outcomes in the COVID-19 pandemic. Extracted data included model type (mechanistic compartmental/agent-based, statistical, both), intervention type (pharmacological, non-pharmacological), and procedures for parameterizing age. Findings are summarized with descriptive statistics and discussed in terms of the evolving COVID-19 situation. Results: The literature search identified 378 results, of which 59 met criteria for data extraction. China, Japan, and South Korea accounted for approximately half of studies, with fewer from South and South-East Asia. Mechanistic models were most common, either compartmental (61.0%), agent-based (1.7%), or combination (18.6%) models. Statistical modeling was applied less frequently (11.9%). Pharmacological interventions were examined in 59.3% of studies, and most considered vaccination, except one study of an antiviral treatment. Non-pharmacological interventions were also considered in 84.7% of studies. Infection, hospitalization, and mortality were outcomes in 91.5%, 30.5%, and 30.5% of studies, respectively. Approximately a third of studies accounted for age, including 10 that also examined mortality. Four of these studies emphasized benefits in terms of mortality from prioritizing older adults for vaccination under conditions of a limited supply; however, one study noted potential benefits to infection rates from early vaccination of younger adults. Few studies (5.1%) considered the impact of vaccination among children. Conclusion: Early in the COVID-19 pandemic, non-pharmacological interventions helped to mitigate the health burden of COVID-19; however, modeling indicates that high population coverage of effective vaccines will complement and reduce reliance on such interventions. Thus, increasing and maintaining immunity levels in populations through regular booster shots, particularly among at-risk and vulnerable groups, including older adults, might help to protect public health. Future modeling efforts should consider new vaccines and alternative therapies alongside an evolving virus in populations with varied vaccination histories.

Modeling the potential public health impact of different vaccination strategies with an omicron-adapted bivalent vaccine in Malaysia.

BACKGROUND: Coronavirus disease 2019 (COVID-19) case numbers have increased following the emergence of the Omicron variant. This study estimated the impact of introducing and increasing the coverage of an Omicron-adapted bivalent booster vaccine in Malaysia. RESEARCH DESIGN AND METHODS: A combined cohort Markov decision tree model was used to compare booster vaccination with an Omicron-adapted bivalent COVID-19 vaccine versus no booster vaccination in Malaysia. The model utilized age-specific data from January 2021 to March 2022 derived from published sources. The outcomes of interest included case numbers, hospitalizations, deaths, medical costs, and productivity losses. The population was stratified into high-risk and standard-risk subpopulations, and the study evaluated the benefits of increased coverage in different age and risk groups. RESULTS: Vaccinating only high-risk individuals and those aged ≥ 65 years was estimated to avert 274,313 cases, 33229 hospitalizations, 2,434 deaths, Malaysian ringgit (MYR) 576 million in direct medical costs, and MYR 579 million in indirect costs. Expanding vaccination coverage in the standard-risk population to 75% was estimated to avert more deaths (31%), hospitalizations (155%), infections (206%), direct costs (206%), and indirect costs (281%). CONCLUSIONS: These findings support broader population Omicron-adapted bivalent booster vaccination in Malaysia with potential for significant health and economic gains.

Explicit-memory multiresolution adaptive framework for speech and music separation.

The human auditory system employs a number of principles to facilitate the selection of perceptually separated streams from a complex sound mixture. The brain leverages multi-scale redundant representations of the input and uses memory (or priors) to guide the selection of a target sound from the input mixture. Moreover, feedback mechanisms refine the memory constructs resulting in further improvement of selectivity of a particular sound object amidst dynamic backgrounds. The present study proposes a unified end-to-end computational framework that mimics these principles for sound source separation applied to both speech and music mixtures. While the problems of speech enhancement and music separation have often been tackled separately due to constraints and specificities of each signal domain, the current work posits that common principles for sound source separation are domain-agnostic. In the proposed scheme, parallel and hierarchical convolutional paths map input mixtures onto redundant but distributed higher-dimensional subspaces and utilize the concept of temporal coherence to gate the selection of embeddings belonging to a target stream abstracted in memory. These explicit memories are further refined through self-feedback from incoming observations in order to improve the system's selectivity when faced with unknown backgrounds. The model yields stable outcomes of source separation for both speech and music mixtures and demonstrates benefits of explicit memory as a powerful representation of priors that guide information selection from complex inputs.

Narrative Review of the Evolution of COVID-19 Vaccination Recommendations in Countries in Latin America, Africa and the Middle East, and Asia.

The rapid rollout of vaccines to combat the coronavirus disease 2019 (COVID-19) pandemic over the past 2 years has resulted in the use of various vaccine platforms and regional differences in COVID-19 vaccine implementation strategies. The aim of this narrative review was to summarize evolving COVID-19 vaccine recommendations in countries in Latin America, Asia, and Africa and the Middle East across various vaccine platforms, age groups, and specific subpopulations. Nuances in primary and booster vaccination schedules were evaluated, and the preliminary impact of such diverse vaccination strategies are discussed, including key vaccine effectiveness data in the era of Omicron-lineage variants. Primary vaccination rates for included Latin American countries were 71-94% for adults and between 41% and 98% for adolescents and children; rates for first booster in adults were 36-85%. Primary vaccination rates for adults in the included Asian countries ranged from 64% in the Philippines to 98% in Malaysia, with corresponding booster rates varying from 9% in India to 78% in Singapore; for adolescents and children, primary vaccination rates ranged from 29% in the Philippines to 93% in Malaysia. Across included African and Middle Eastern countries, primary vaccination rates in adults varied widely from 32% in South Africa to 99% in the United Arab Emirates; booster rates ranged from 5% in South Africa to 60% in Bahrain. Evidence from the regions studied indicates preference of using an mRNA vaccine as a booster on the basis of safety and effectiveness of observed real-world data, especially during circulation of Omicron lineages. Vaccination against COVID-19 remains of paramount importance to reduce the burden of disease; strategies to overcome vaccine inequity, fatigue, hesitancy, and misinformation and to ensure adequate access and supply are also important.

The rise and fall of felbamate as a treatment for partial epilepsy--aplastic anemia and hepatic failure to blame?

Felbamate has been approved for refractory partial seizures since the early nineties. Due to safety concerns regarding its use, namely, in aplastic anemia and hepatic failure, felbamate's use has been restricted and a 'Black Box' warning has been inserted. Nonetheless, it is a useful drug in refractory cases of partial epilepsy. There are certain precautions which can prevent and minimize the serious idiosyncratic reactions associated with felbamate, thereby providing an option in refractory cases where no other drug works.

A drug utilization study of cognition enhancers in dementia in a tertiary care hospital in mumbai.

BACKGROUND: Cognitive decline is one of the important factors undermining the quality of life in geriatric patients. Although the WHO has declared 'Dementia' as a priority health condition.Cognitive neuropharmacology is still in its infancy and there is no general consensus on the use of cognition enhancing (CE) drugs in humans. Since drug utilization data of CEs in dementia are scarce, we conducted a study to describe the observed patterns of CE drug use, compare it to the current recommendations and conduct a preliminary cost analysis. METHODS: A prospective cross sectional drug utilization study of 100 prescriptions of patients of both sexes and all ages suffering from dementia attending the Neurology and Psychiatry clinics was undertaken as per the WHO - DUS and the STROBE guidelines. RESULTS: In all, the 100 prescriptions contained 322 drugs, out of which, 168 were CE drugs. 38.2% of the drugs were prescribed by generic names. Donepezil, Memantine, Piracetam, Rivastigmine and Gallantamine were prescribed to 76%, 34%, 8%, 6% and 0%, respectively. The PDD/DDD ratio of Donepezil and Memantine were 1.36 and 0.94, respectively. The average cost per prescription was INR 626.29 or USD 9.5. CONCLUSION: Principles of rational prescribing were followed. Donepezil and Memantine were the most commonly prescribed drugs and hence should be included in the hospital drug schedule. Piracetam should not be prescribed because of doubtful benefits and high cost. Antipsychotics should be used in geriatric dementia patients very judiciously. A major part of the total cost per prescription was borne by the patient.

A cross-sectional study to evaluate the awareness and attitudes of physicians towards reducing the cost of prescription drugs, Mumbai.

BACKGROUND: In India, about half of the total health expenditure is spent on medicines. The projected increase in various diseases coupled with the skyrocketing drug prices have further compounded the drug cost burden. We conducted a study to assess the awareness, attitudes, and practices of physicians with regard to various cost containment measures and the factors affecting them. METHODS: A cross-sectional, questionnaire-based, observational study was conducted over a period of 3 months among 200 physicians, after permission from the Institutional Ethics Committee, at the Grant Medical College and Sir J J Group of Hospitals, Mumbai. The STROBE (Strengthening The Reporting of OBservational studies in Epidemiology) guidelines were followed. RESULTS: Cost considerations were important to 97 % of government doctors (GDs) and 72 % of private doctors (PDs). Eighty percent of both GDs and PDs said that safety and efficacy were more important than cost. Seventy-one percent of GDs and 65 % of PDs knew about the various cost reduction methods. Twenty-four percent of GDs and 65 % of PDs said that they graded drugs according to cost. Ninety-four percent of GDs and 73 % of PDs said that patent protection should not be extended to life-saving drugs. Sixty-four percent of GDs and 10 % of PDs, and 20 % of GDs and 10 % of PDs were in favor of the stepwise introduction of drugs and the use of generics, respectively. Factors precluding the use of cheaper alternatives were narrow therapeutic index drugs (43.5 %) and fear of substandard quality (38.5 %). CONCLUSION: Doctors are indeed concerned about the high cost of drugs. More awareness needs to be created about the use of cheaper generics. The government has a very important role to play in reducing the cost of prescription drugs and making healthcare affordable.

A drug utilization study of psychotropic drugs prescribed in the psychiatry outpatient department of a tertiary care hospital.

BACKGROUND: Psychiatric disorders are one of the major causes of morbidity. Development of newer drugs like SSRIs and atypical antipsychotics has altered the treatment paradigms. Various factors like cost of drugs, local paradigms, etc. play a role in the selection of drug therapy and hence, affect the outcome. Keeping this in mind, we conducted a study to delineate the various drugs used in psychiatric disorders, to find discrepancies, if any, between the actual and the ideal prescribing pattern of psychotropic drugs and to conduct a cost analysis. MATERIAL AND METHODS: After our institutional ethics committee approved, a retrospective cross sectional drug utilization study of 600 prescriptions was undertaken. Preparation of the protocol and conduct of the study was as per the WHO - DUS and the STROBE guidelines. RESULTS: Drug use indicators - In 600 prescriptions, 1074 (88.25%) were psychotropic drugs. The utilization from the National and WHO EML was 100% and 90%, respectively. Average number of psychotropic drugs per prescription was 1.79 ± 1.02 (SD). 22.5% of the prescriptions contained psychotropic FDCs. 76.01% of drugs were prescribed by generic name. Percentage of psychotropic drugs prescribed from the hospital drug schedule and psychotropic drugs actually dispensed from the hospital drug store were 73.1% and 62.3%, respectively. Drug utilization pattern in different psychiatric disorders - Most commonly prescribed drugs for schizophrenia, bipolar disorders, depression and anxiety disorders were trifluoperazine + trihexiphenydyl (63.9%), carbamazepine (17.2%), amitriptyline (34.9%), and diazepam (23.8%), respectively. The least commonly prescribed drugs were levosulpiride (1.7%), lithium (1.3%), bupropion (4.7%) and clozapine (1.9%), respectively. The PDD/DDD ratio of three drugs - haloperidol, pimozide and amitriptyline - was equal to one. The cost borne by the hospital was 116, i.e., 65.2% of the total cost. The cost index of clozapine was 11.2. CONCLUSION: Overall, the principles of rational prescribing were followed. The hospital drug schedule should include more SSRIs. The practice of using 1(st) generation/ typical anti-psychotics as the first line was as per current recommendations. Anti-cholinergics should be used only in selected cases of patients on anti-psychotics. The use of diazepam should be curtailed and it should be used for short term only.