Implementation of Nurse Prescriptions throughout the Public Health System in Catalonia (2021-2022).

BACKGROUND: Nurses in Catalonia have always prescribed health advice, health products, and medication in line with the professional competency of the discipline. Legislation about nurse prescriptions and the implementation of nurse prescribing varies widely among different countries. This article reports data regarding nurse prescribing in Catalonia in 2021 and 2022. METHODS: This retrospective longitudinal study analyzed data from all care-providing units in Catalonia's integrated public health system. RESULTS: The number of nurse prescriptions increased from 139,435 in 2021 to 573,822 in 2022, and the number of nurses issuing prescriptions increased from 3604 in 2021 to 5563 in 2022. The proportion of prescriptions for different products was similar in the two years analyzed. Prescriptions for medication increased by 7.5% in 2022. CONCLUSIONS: Nurse prescribing is a recent advance in Catalonia. Despite some difficulties in rollout, the data indicate that this practice is becoming consolidated, as in other European countries.

Longitudinal changes in adverse effects reporting in multiple dietary supplement classifications: The US military dietary supplement use study.

Over 70% of United States military service members (SMs) regularly use dietary supplements (DSs) and about 18% have reported adverse effects (AEs) associated with use. This investigation examined longitudinal changes in AEs reporting among DS users. On two separate occasions 1.3 ± 0.2 years apart (mean ± standard deviation), 5778 SMs completed identical questionnaires on DS use and associated AEs. Among SMs reporting DS use ≥1 time/week, ≥1 AE was reported by 19% and 15% in the baseline and follow-up phases, respectively. The risk of reporting DS use at follow-up was similar among those reporting and not reporting AEs at baseline for most DS categories including prohormones, proteins/amino acids, individual vitamins and minerals, multivitamin/multiminerals, herbals, fish oils, joint health products, and other DSs. An exception was combination products where those reporting AEs at baseline had an increased risk of use at follow-up (risk ratio = 1.13, 95% confidence interval = 1.06-1.09). Those reporting AEs at baseline and continuing DS use in the follow-up were more likely to report AEs at follow-up compared to those not reporting baseline AEs. In conclusion, AEs reported at baseline did not deter many participants from using DSs in the follow-up period, and many SMs reporting AEs at baseline continued reporting them at follow-up.

Health Outcomes of Social Pension Expansion: A Quasi-Experiment Among Older Adults in Hong Kong.

A social pension, regarded as a reliable source of income, has the potential to significantly influence the overall wellbeing of vulnerable older adults. This study aimed to extend the understanding of the effects of social pension expansion beyond its economic impacts to encompass recipients' health status. Using three-wave data from a representative sample of older adults, we employed a quasi-experimental assessment model to evaluate the impact of a recent social pension expansion in Hong Kong on health-related consumption and health outcomes among older adults. The results of the triple difference estimations revealed that an increased social pension significantly enhanced older people's engagement in entertainment activities, utilization of healthcare services, and expenditures on preventive health products. Furthermore, the increased social pension was found to have a significant positive effect on mitigating poor self-rated health and poor sleep quality. However, it did not have a significant impact on the prevalence of depression. These findings suggest that social pension expansion should be coordinated with other policy initiatives to comprehensively improve the physical and mental health of older adults.

A model of purchase intention of complementary and alternative medicines: the role of social media influencers' endorsements.

BACKGROUND: Social Media Influencers (SMIs) are a fashionable way of marketing products by creating electronic word-of-mouth (e-WOM) on social media. The marketing of complementary and alternative medicines (CAMs) by SMIs is becoming increasingly popular and gaining credibility within consumers on social media platforms. Nonetheless, advising about healthcare products on social media should be examined as it is different from endorsing other kinds of commercial products. The aim of this study is to develop a model that provides the underlying mechanisms of the stimuli of SMIs on social media towards consumers' purchase intention of CAMs. METHODS: This study used best fit framework synthesis methods to develop the model. A priori theory selection was conducted by identifying a BeHEMoTh strategy (Behavior of Interest, Health context, Exclusions and Models or Theories) to systematically approach identifying relevant models and theories relative to the research aim. Further evidence derived from primary research studies that describe the behavior identified is coded against selected a priori theory to develop the model. RESULTS: This study presents a novel model for understanding the purchase behavior of CAMs using SMIs as a marketing strategy. The model included two well-known theories (theory of planned behaviour theory and source credibility theory) as well as extensive existing research from a multidisciplinary perspective. The model is exclusively designed to help identify elements affecting perceived source credibility and factors that have an influence over consumers' preferences to purchase CAMs by taking into consideration SMIs' endorsements. CONCLUSIONS: This study provides unique insights introducing new research areas to health literature and offers, new roles for healthcare professionals in this digital era by gaining new skills and competencies required to provide more credible and accurate information about CAMs. The study also highlights the new marketing era of online health-related product endorsements and recommends that policymakers and researchers carefully evaluate the impact of SMI's on the use of CAMs, as well as to regulate the content of these promotional materials.

Cancer patients' behaviors and attitudes toward natural health products.

BACKGROUND: Natural health products (NHPs), including vitamins, minerals, and herbal supplements, are the most common complementary and alternative medicine (CAM) among cancer patients. Our survey determined the attitudes and behaviors of cancer patients toward natural complementary therapies that should be considered to implement an integrative approach in the future. METHODS: Our survey was conducted in four hospitals in Belgium. Questionnaires were posted online from October 2020 to October 2021 for cancer patients. Descriptive statistics were used to analyze the data. A [Formula: see text] test was applied to study the type of NHP consumed according to diagnosis time. Fischer's exact test compared patients who had changed their consumption since diagnosis and those who had not. RESULTS: Out of 349 questionnaires collected, only 59 met all inclusion criteria. 83.1 % of the patients agreed that conventional medicine (CM) could benefit from complementary therapies, but they did not estimate (72.3 % of the patients) that those latter are more effective than conventional medicine. More than half of the patients used five or more NHPs. The most frequent NHPs consumed daily were vitamins (64.4 %), followed by other products (i.e., probiotics, gemmotherapy, birch sap and omega 3/6) (42.4 %) and herbs (40.7 %). Almost all patients started taking NHPs before their cancer diagnosis, but 72.7 % have changed their consumption significantly (p = 0.009) since their diagnosis. Boosting the immune system (79.7 %) and limiting conventional treatment side effects (76.9 %) were the most common reasons for NHPs' use. 74.4 % of the patients did not take complementary therapies to delay or avoid conventional treatment. CONCLUSIONS: The combination and high diversity of NHPs consumption highlight the importance of educating patients and healthcare providers (HCPs) about the risk of drug interactions associated with these natural products. Most cancer patients are more interested in using this non-mainstream medicine to complement their conventional treatment than as an alternative. Knowing the patients' reasons and understanding patients' attitudes toward NHPs will be essential for HCPs to address NHPs' use.

Classification system for nanotechnology-enabled health products with both scientific and regulatory application.

The lack of specific regulatory guidelines for nanotechnology-enabled health products (NHPs) is hampering development and patient access to these innovative technologies. Namely, there is an urgent need for harmonized regulatory definitions and classification systems that allow establishing a standardized framework for NHPs regulatory assessment. In this work, a novel classification system for NHPs is proposed. This classification can be applied for sorting nano-based innovations and regulatory guidelines according to the type of NHPs they address. Said methodology combines scientific and regulatory principles and it is based on the following criteria: principal mode of action, chemical composition, medical purpose and nanomanufacturing approach. This classification system could serve as a useful tool to sensor the state of the art of NHPs which is particularly useful for regulators to support strategy development of regulatory guidelines. Additionally, this tool would also allow manufacturers of NHPs to align their development plans with their applicable guidelines and standards and thus fulfill regulators expectations.

Why There Is a Need to Promote Media Literacy in the Use of Medicines and Health Products in Thai Older Adults?

This cross-sectional study aimed to explore levels of health literacy and factors related to health literacy in choosing medicines and health products among Thai older adults who use smartphones. The study was carried out during March to November 2021 among Senior Schools in the North-eastern of Thailand. The analysing with descriptive statistics Chi-square test and the multiple logistic regression were used to test the association between variables. The results showed that most participants have a low level of health literacy in medication and health products usage. The risking factors that affected to a low-level health literacy were living in a rural area and ability to use a smartphone. Therefore, there should be knowledge enhancement for the older adults with smartphone. Especially, searching information skill and choosing the qualitative media before deciding to buy and use healthy drugs or health products.

Development of Indirect Health Data Linkage on Health Product Use and Care Trajectories in France: Systematic Review.

BACKGROUND: European national disparities in the integration of data linkage (ie, being able to match patient data between databases) into routine public health activities were recently highlighted. In France, the claims database covers almost the whole population from birth to death, offering a great research potential for data linkage. As the use of a common unique identifier to directly link personal data is often limited, linkage with a set of indirect key identifiers has been developed, which is associated with the linkage quality challenge to minimize errors in linked data. OBJECTIVE: The aim of this systematic review is to analyze the type and quality of research publications on indirect data linkage on health product use and care trajectories in France. METHODS: A comprehensive search for all papers published in PubMed/Medline and Embase databases up to December 31, 2022, involving linked French database focusing on health products use or care trajectories was realized. Only studies based on the use of indirect identifiers were included (ie, without a unique personal identifier available to easily link the databases). A descriptive analysis of data linkage with quality indicators and adherence to the Bohensky framework for evaluating data linkage studies was also realized. RESULTS: In total, 16 papers were selected. Data linkage was performed at the national level in 7 (43.8%) cases or at the local level in 9 (56.2%) studies. The number of patients included in the different databases and resulting from data linkage varied greatly, respectively, from 713 to 75,000 patients and from 210 to 31,000 linked patients. The diseases studied were mainly chronic diseases and infections. The objectives of the data linkage were multiple: to estimate the risk of adverse drug reactions (ADRs; n=6, 37.5%), to reconstruct the patient's care trajectory (n=5, 31.3%), to describe therapeutic uses (n=2, 12.5%), to evaluate the benefits of treatments (n=2, 12.5%), and to evaluate treatment adherence (n=1, 6.3%). Registries are the most frequently linked databases with French claims data. No studies have looked at linking with a hospital data warehouse, a clinical trial database, or patient self-reported databases. The linkage approach was deterministic in 7 (43.8%) studies, probabilistic in 4 (25.0%) studies, and not specified in 5 (31.3%) studies. The linkage rate was mainly from 80% to 90% (reported in 11/15, 73.3%, studies). Adherence to the Bohensky framework for evaluating data linkage studies showed that the description of the source databases for the linkage was always performed but that the completion rate and accuracy of the variables to be linked were not systematically described. CONCLUSIONS: This review highlights the growing interest in health data linkage in France. Nevertheless, regulatory, technical, and human constraints remain major obstacles to their deployment. The volume, variety, and validity of the data represent a real challenge, and advanced expertise and skills in statistical analysis and artificial intelligence are required to treat these big data.

The Potential of Edible and Medicinal Resource Polysaccharides for Prevention and Treatment of Neurodegenerative Diseases.

As natural medicines in complementary and alternative medicine, edible and medicinal resources are being gradually recognized throughout the world. According to statistics from the World Health Organization, about 80% of the worldwide population has used edible and medicinal resource products to prevent and treat diseases. Polysaccharides, one of the main effective components in edible and medicinal resources, are considered ideal regulators of various biological responses due to their high effectiveness and low toxicity, and they have a wide range of possible applications for the development of functional foods for the regulation of common, frequently occurring, chronic and severe diseases. Such applications include the development of polysaccharide products for the prevention and treatment of neurodegenerative diseases that are difficult to control by a single treatment, which is of great value to the aging population. Therefore, we evaluated the potential of polysaccharides to prevent neurodegeneration by their regulation of behavioral and major pathologies, including abnormal protein aggregation and neuronal damage caused by neuronal apoptosis, autophagy, oxidative damage, neuroinflammation, unbalanced neurotransmitters, and poor synaptic plasticity. This includes multi-target and multi-pathway regulation involving the mitochondrial pathway, MAPK pathway, NF-κB pathway, Nrf2 pathway, mTOR pathway, PI3K/AKT pathway, P53/P21 pathway, and BDNF/TrkB/CREB pathway. In this paper, research into edible and medicinal resource polysaccharides for neurodegenerative diseases was reviewed in order to provide a basis for the development and application of polysaccharide health products and promote the recognition of functional products of edible and medicinal resources.

Application of Polyphenols and Flavonoids in Oncological Therapy.

The use of naturally derived drugs in anti-cancer therapies has grown exponentially in recent years. Among natural compounds, polyphenols have shown potential therapeutic applications in treatment due to their protective functions in plants, their use as food additives, and their excellent antioxidant properties, resulting in beneficial effects on human health. Building more efficient cancer therapies with fewer side effects on human health can be achieved by combining natural compounds with conventional drugs, which are typically more aggressive than natural chemicals with polyphenols. This article reviews a wide variety of studies where polyphenolic compounds can play a key role as anticancer drugs, alone or in combination with other drugs. Moreover, the future directions of applications of various polyphenols in cancer therapy are shown.

Regulatory registration timelines of generic medicines in South Africa: Assessment of the performance of SAHPRA between 2011 and 2022.

BACKGROUND: Various regulatory authorities are experiencing backlogs of applications which result in delayed access to medicines for patients. The objective of this study is to critically assess the registration process utilised by SAHPRA between 2011 and 2022 and determine the fundamental root causes for the formation of a backlog. The study also aims to detail the remedial actions that were undertaken which resulted in the development of a new review pathway termed the risk-based assessment approach for regulatory authorities experiencing backlogs to implement. METHODS: A sample of 325 applications was used to evaluate the end-to-end registration process employed for the Medicine Control Council (MCC) process between 2011 and 2017; 129 applications were used for the backlog clearance project (BCP) between 2019 and 2022; 63 and 156 applications were used for the risk-based assessment (RBA) pilot studies in 2021 and 2022, respectively. The three processes are compared, and the timelines are discussed in detail. RESULTS: The longest median value of 2092 calendar days was obtained for the approval times between 2011 and 2017 using the MCC process. Continuous process optimisation and refinement are crucial to prevent recurring backlogs and hence implementation of the RBA process. Implementation of the RBA process resulted in a shorter median approval time of 511 calendar days. The finalisation timeline by the Pharmaceutical and Analytical (P&A) pre-registration Unit, which conducts the majority of the evaluations, is used as a tool for the direct comparison of the processes. The finalisation timeline for the MCC process was a median value of 1470 calendar days, the BCP was 501 calendar days and the RBA process phases 1 and 2 were 68 and 73 calendar days, respectively. The median values of the various stages of the end-to-end registration processes are also analysed in order to build efficiency within the process. CONCLUSIONS: The observations from the study have identified the RBA process which can be implemented to reduce regulatory assessment times while assuring the timeous approval of safe and effective, quality medicines. The continuous monitoring of a process remains one of the critical tools required to ensure the effectiveness of a registration process. The RBA process also becomes a better alternative for generic applications that do not qualify to undergo the reliance approach due to its drawbacks. This robust procedure can therefore be utilised by other regulatory agencies that may have a backlog or want to optimise their registration process.

[Pharmaceutical supply chain of a New Caledonian hospital: Overview, risk assessment and future prospects]. / Approvisionnement pharmaceutique au centre hospitalier territorial de Nouvelle-Calédonie : état des lieux, évaluation et perspectives.

INTRODUCTION: The supply circuit for health products in New Caledonia has characteristics and specificities linked to its geographical situation (extended delivery time, freight forwarder) and its local policy (own currency, fundings, legislation and custom fees). A risk management approach should provide an upgrade of the supply process safety. METHODS: A system overview is carried out thanks to the processes description (operational and cross-functional). A risk map associated with the FMEA methodology (Failure Mode Effects Analysis) identifies the most critic modes of failure, for which safety action must be taken. A specific rating is introduced when the mode of failure concerns sensitive health products. RESULTS: The mapping identified 32 modes of failure which may affect the clinical management of the patients. Concerning sensitive health products, 11 modes of failure were deemed "to be monitored". None of the failure modes were considered as "to treat as a priority". CONCLUSION: The security process is ensured by the logistics and accounting unit, internal to the pharmacy structure. Securisation might include deployment of a data exchange system, sensitive health products identification or collaboration with neighbouring countries to import health products. Supply chain reinforcement mesures can be implemented by the public authorities, but should also be sought through territorial collaboration or via the PharmApprOM community of practice bringing together pharmacists in French overseas regions.

A randomized, double-blind, placebo-controlled, cross-over trial to evaluate the effect of EstroSense® on 2-hydroxyestrone:16α-hydroxyestrone ratio in premenopausal women.

OBJECTIVES: Some estrogen metabolites are associated with increased breast cancer risk, while others are protective. Research efforts have focused on modifiable factors, including bioactive compounds found in food or supplements, promoting estrogen profiles with anti-cancer properties. EstroSense® is a nutraceutical product with bioactive compounds, including Indole-3-carbinol and green-tea catechins, which may favourably affect estrogen profiles. This study was conducted to determine if EstroSense use, compared to placebo, promotes a higher urinary 2-hydroxyestrone:16α-hydroxyestrone ratio (2-OHE1:16α-OHE1), a biomarker associated with a lowered risk of breast cancer. METHODS: A total of 148 premenopausal women were recruited from British Columbia, Canada to participate in a randomized, double-blind, cross-over, multicentre, placebo-controlled study in which women were randomized to a treatment sequence that consisted of either EstroSense®, followed by placebo or vice-versa. The women were instructed to consume three capsules per day of EstroSense® or the placebo for three menstrual cycles (∼12 weeks). The primary outcome was the measurement of 2-OHE1:16α-OHE1 in casual samples at baseline and after each treatment phase. RESULTS: After 12 weeks of intervention, the mean (95% CI) urinary 2-OHE1:16α-OHE1 was 4.55 (2.69, 6.42) (p<0.001) higher following EstroSense than placebo adjusted for baseline values. CONCLUSIONS: EstroSense use led to markedly higher urinary 2-OHE1:16α-OHE1 than the placebo, a biomarker associated with a lower risk of breast cancer. REGISTRATION: http://clinicaltrials.gov (NCT02385916).

Historical Aspects of Herbal Use and Comparison of Current Regulations of Herbal Products between Mexico, Canada and the United States of America.

Increased life expectancy and high costs of medicines and medical care have led to the use of herbal products. However, these items may contain toxic compounds that have an impact on public health. We will focus on the regulatory aspects and differences of these products marketed in the North American region (USA-Mexico-Canada) from government websites and selected literature. Mexico has an ancestral tradition of using plants for the treatment, improvement, and maintenance of human health as compared with Canada and the USA Currently, the use of herbal products in this region has a regulatory framework. The legal framework in these three countries is related to their history, idiosyncrasies, socio-economic and cultural aspects. Therefore, there are different public policies for herbal products consumed in the region. Mexico has a more specific classification of these products. In Canada, all herbal products are classified as natural health products and the safety and efficacy must be scientifically proven. In the USA, the development of botanical drugs is very recent. In particular, both herbal products classified as food supplements in Mexico and dietary supplements in the USA may have risks in both safety and efficacy.

Role and Importance of Functional Food Packaging in Specialized Products for Vulnerable Populations: Implications for Innovation and Policy Development for Sustainability.

Specialized products can be needed to help meet the nutrition requirements of vulnerable populations, including infants and young children, those who are ill, and older adults. Laws and regulations delineate distinct categories for such products including medical foods or formulated liquid diets, foods for special dietary use (FSDUs), infant formulas, and natural health products (NHPs). Yet, the literature is limited regarding the role and importance of functional and sustainable packaging for specialized products. This perspective review describes these unique product categories and the role of packaging as well as regulatory considerations. Furthermore, reviewed are how waste reduction strategies and emerging legislative/regulatory policies in the United States and Canada may not adequately address the functional packaging requirements for specialized products. The paper concludes by offering perspectives for emerging innovations and policy development for sustainability.

Collaborative reliance in medicine safety and quality regulation: Investigation of experiences in handling N-nitrosamine impurities among ZaZiBoNa participating countries.

Introduction: The presence of N-nitrosamine impurities in medicines raised concerns globally as they are genotoxic and probable human carcinogens. A review of N-nitrosamine impurities in medicines provides an opportunity for National Regulatory Authorities (NRAs) to ensure that corrective and preventive actions are applied so that safe and good quality medicines are made available to the public. This study aimed to investigate the experiences on reviews conducted by NRAs from various Southern African Development Community countries which participate in the regional work-sharing forum, ZaZiBoNa, on the quality and safety data due to the presence of N-nitrosamine impurities in medicines. Methods: A comparative, descriptive study using mixed methods was conducted. Purposive sampling was applied in selecting research participants based on their participation status in the ZaZiBoNa initiative. A standardized questionnaire structured into five parts was completed by ZaZiBoNa focal persons/nominated individuals to determine the experience of each NRA in addressing the safety and quality issues related to the presence of N-nitrosamine impurities in the affected medicines. Profiled medicines included sartans, ranitidine, metformin, rifampicin, and rifapentine. Results: Sartan medicines had been reviewed by all countries participating in the ZaZiBoNa initiative. Although most NRAs have yet to conduct reviews on other profiled medicines, evaluations have been implemented to ensure access to safe and good quality medicines within the region. Most countries experienced challenges in communicating with applicants or marketing authorization holders (MAHs) on reviewing N-nitrosamine impurities in their medicines. The majority of NRAs agree that there is a need for further collaboration efforts to review N-nitrosamine impurities in medicines. Conclusion: The review of N-nitrosamine impurities in the profiled medicines by NRAs within the region has demonstrated the importance of enhanced regulatory oversight to safeguard against the risks associated with medicines. Collaborative reliance on the review of the safety and quality of medicine, continuous monitoring, implementation and review of processes, testing methods, and regular engagements with stakeholders could be essential in ensuring adequate control of N-nitrosamine impurities in medicines.

Prevalence of prescription and non-prescription polypharmacy by frailty and sex among middle-aged and older Canadians.

Background: Estimates of polypharmacy have primarily been derived from prescription claims, and less is known about the use of non-prescription medications (alone or in combination with prescription medications) across the frailty spectrum or by sex. Our objectives were to estimate the prevalence of polypharmacy (total, prescription, non-prescription, and concurrent prescription and non-prescription) overall, and by frailty, sex and broad age group. Data: Canadian Health Measures Survey, Cycle 5, 2016 to 2017. Methods: Among Canadians aged 40 to 79 years, all prescription and non-prescription medications used in the month prior to the survey were documented. Polypharmacy was defined as using five or more medications total (prescription and non-prescription), prescription only and non-prescription only. Concurrent prescription and non-prescription use was defined as two or more and three or more of each. Frailty was defined using a 31-item frailty index (FI) and categorized as non-frail (FI ≤ 0.1) and pre-frail or frail (FI > 0.1). Survey-weighted descriptive statistics were calculated overall and age standardized. Results: We analyzed 2,039 respondents, representing 16,638,026 Canadians (mean age of 56.9 years; 51% women). Overall, 52.4% (95% confidence interval [CI] = 47.3 to 57.4) were defined as pre-frail or frail. Age-standardized estimates of total polypharmacy, prescription polypharmacy and concurrent prescription and non-prescription medication use were significantly higher among pre-frail or frail versus non-frail adults (e.g., total polypharmacy: 64.1% versus 31.8%, respectively). Polypharmacy with non-prescription medications was common overall (20.5% [95% CI = 16.1 to 25.8]) and greater among women, but did not differ significantly by frailty. Interpretation: Polypharmacy and concurrent prescription and non-prescription medication use were common among Canadian adults, especially those who were pre-frail or frail. Our findings highlight the importance of considering non-prescribed medications when measuring the exposure to medications and the potential risk for adverse outcomes.

Bioequivalence Common Deficiencies in Generic Products Submitted for Registration to the South African Health Products Regulatory Authority (SAHPRA).

BACKGROUND: The cost of healthcare has become expensive globally, of which the greater part of the money is spent on buying innovator medicines. In order to make medicine affordable, the development of generic medicines has become paramount. The science of bioequivalence studies of generic products to demonstrate therapeutic equivalence with innovator products has been developed over the last 50 years. These studies cost far less as compared to innovator products thereby reducing the cost of medicines. Accelerating access to medicines has become an increasing challenge due to insufficient resources from regulatory authorities, while pharmaceutical industry continues to expand. An investigation on the deficiencies identified during scientific assessments by SAHPRA in submitted bioequivalence studies is therefore paramount. Identification and publication of these deficiencies will assist in accelerating the access of medicines to patients. OBJECTIVE: The aim of the study is to investigate the types and frequency of the common deficiencies observed in the bioequivalence section of generic submissions to SAHPRA. The study was conducted retrospectively over a 7-year period (2011-2017) for generic products that were finalised by the Pharmaceutical and Analytical pre-registration Unit. A more recent analysis on common deficiencies witnessed for applications assessed between 2020 and 2021 was also done to illustrate the consistency in the evaluation practises adopted by SAHPRA. METHODS: There were 3148 applications finalised between 2011 and 2017, and to attain a representative sample for the study, statistical sampling was conducted. The multi-stage sampling called stratified systematic sampling was selected as the method of choice. The sample size was obtained using the statistical tables found in the literature and confirmed by a sample size calculation resulting in the selection of 325 applications (Fig. 2a). Additionally, 300 master applications were assessed between 2020 and 2021 for up-to-date data (Fig. 2b). All the deficiencies were collected and categorised according to the ICH E3 guideline and components relevant to biostudies. RESULTS: A total of 2458 deficiencies were collected from the selected sample size for applications finalised between 2011 and 2017 where a biostudy was submitted. The majority of the identified deficiencies were from the following categories; in vitro dissolution testing and specifications (18%), study design (17%), details on the test and reference products (16%), issues on sample analysis (16%), and statistical analysis (10%) (Fig. 3). From the applications assessed in 2020-2021, 492 deficiencies were identified with a similar trend compared to those finalised between 2011 and 2017. Comparison of the deficiencies with those reported by the USFDA and WHO PQTm is discussed with similarities outlined. CONCLUSIONS: The five most common deficiencies observed were extensively discussed. The outcomes of this study will guide pharmaceutical companies, sponsors, and Clinical Research Organisations (CROs) in submitting quality biostudies which will reduce turnaround times for registration and accelerate access to medicines for patients. In addition, the deficiencies identified will assist assessors from the different regulatory authorities to improve on their bioequivalence assessment.

POSS-based fluorescence sensor for rapid analysis of ß-carotene in health products.

In recent years, fluorescent organic-inorganic hybrid nanomaterials have received much interest as potential fluorescent sensor materials. In this study, fluorescent organic-inorganic hybrid nanomaterials (POSS@ANT) were created using polyhedral oligomeric silsesquioxane as the precursor and 9,10-bromoanthracene as the monomer. The morphology and composition of POSS@ANT, as well as its pore characteristics and fluorescence properties were studied. POSS@ANT displayed steady fluorescence emission at an excitation wavelength of 374 nm. Next, a ß-carotene fluorescence sensor was developed using the capacity of ß-carotene to quench the fluorescence of POSS@ANT. The quenching process is linked to acceptor electron transfer and energy transfer, and the sensor has a high selectivity for ß-carotene. This ß-carotene fluorescence analysis method that we established has a linear range of 0.2-4.3 mg/L and a detection limit of 0.081 mg/L. Finally, it was used to quantify ß-carotene in health products, the recovery rate was 91.1-109.9%, the relative standard deviation (RSD) was 2.2-4.3%, and the results were comparable with the results of high-performance liquid chromatography. The approach is reliable and can be used to determine ß-carotene in health products.