Effects Of Medicinal Products Research Articles

The Increasing Demand for Skilled Professionals in the Field of Pharmacovigilance

ABSTRACT The pharmaceutical sector is experiencing rapid advancements in drug discovery, strict regulations, and a commitment to patient safety. This has led to an increased demand for skilled pharmacovigilance experts who can ensure the safety and effectiveness of medicinal products. Several factors contribute to this demand. The expanding pharmaceutical landscape leads to the need for thorough investigation of the safety profile of new medications and treatments. The increasing volume of pharmaceutical products also requires close monitoring for safety and efficacy. Strict regulatory requirements from global agencies further emphasize the need for a robust pharmacovigilance system. The industry’s focus on patient safety drives the demand for professionals who can effectively manage and analyze safety data. The rise of biologics and biosimilars presents additional challenges in monitoring and assessing safety profiles, creating a need for specialized expertise. Furthermore, the globalization of clinical trials and technological advancements, such as artificial intelligence (AI) and machine learning (ML), require experts who can integrate these tools into pharmacovigilance methods. There are certain skill sets that are crucial for pharmacovigilance professionals. These include regulatory knowledge, data analysis and interpretation, case processing, signal detection and risk management, medical and scientific expertise, communication skills, and technological proficiency. There are various career opportunities in pharmacovigilance, including pharmacovigilance officer, pharmacovigilance scientist, medical reviewer, pharmacovigilance team lead/manager, regulatory affairs specialist, and consultant and trainer. Future trends in the field include the convergence of AI and ML, the use of real-world evidence for postmarketing surveillance and drug safety monitoring, collaboration, and outsourcing for PV projects, and the need to tailor pharmacovigilance approaches to personalized medicine. In conclusion, the pharmaceutical industry’s evolution and commitment to patient safety have created a growing need for skilled professionals in pharmacovigilance. Investments in the development and education of these professionals are essential for the advancement of drug safety and public health.

The Increasing Demand for Skilled Professionals in the Field of Pharmacovigilance

ABSTRACT The pharmaceutical sector is experiencing rapid advancements in drug discovery, strict regulations, and a commitment to patient safety. This has led to an increased demand for skilled pharmacovigilance experts who can ensure the safety and effectiveness of medicinal products. Several factors contribute to this demand. The expanding pharmaceutical landscape leads to the need for thorough investigation of the safety profile of new medications and treatments. The increasing volume of pharmaceutical products also requires close monitoring for safety and efficacy. Strict regulatory requirements from global agencies further emphasize the need for a robust pharmacovigilance system. The industry’s focus on patient safety drives the demand for professionals who can effectively manage and analyze safety data. The rise of biologics and biosimilars presents additional challenges in monitoring and assessing safety profiles, creating a need for specialized expertise. Furthermore, the globalization of clinical trials and technological advancements, such as artificial intelligence (AI) and machine learning (ML), require experts who can integrate these tools into pharmacovigilance methods. There are certain skill sets that are crucial for pharmacovigilance professionals. These include regulatory knowledge, data analysis and interpretation, case processing, signal detection and risk management, medical and scientific expertise, communication skills, and technological proficiency. There are various career opportunities in pharmacovigilance, including pharmacovigilance officer, pharmacovigilance scientist, medical reviewer, pharmacovigilance team lead/manager, regulatory affairs specialist, and consultant and trainer. Future trends in the field include the convergence of AI and ML, the use of real-world evidence for postmarketing surveillance and drug safety monitoring, collaboration, and outsourcing for PV projects, and the need to tailor pharmacovigilance approaches to personalized medicine. In conclusion, the pharmaceutical industry’s evolution and commitment to patient safety have created a growing need for skilled professionals in pharmacovigilance. Investments in the development and education of these professionals are essential for the advancement of drug safety and public health.

Influence of α<sub>2</sub>-Adrenoreceptor Antagonists on Electroencephalogram Characteristics after Dexmedetomidine Administration in Rabbits

The humane treatment of laboratory animals is an integral part of good laboratory practice. It remains relevant to study the anaesthetic effects of various medicinal products helping to reduce pain and distress in laboratory animals.The aim of the study was to compare the effects of the α2 blockers proroxan and atipamezole on changes in electroencephalogram rhythm index ratios after dexmedetomidine administration.Materials and methods. The study used male Soviet chinchilla rabbits weighing 3.0±0.3 kg (n=12). Study animals received single injections of 100 μg/kg dexmedetomidine subcutaneously, 50 μg/kg atipamezole intramuscularly, and 170 μg/kg proroxan intravenously (equimolar to the dose of dexmedetomidine). The effects of these medicinal products were evaluated by pharmacoelectroencephalography. The authors recorded electroencephalograms using cup electrodes and a Neuron-Spectrum-1 8-channel encephalograph (Neurosoft, Russia) with a bandwidth of 0.5–35 Hz and a sampling frequency of 500 Hz. The distribution of quantitative characteristics was checked for normality using the Shapiro–Wilk W test. The authors used one-way ANOVA with Dunnett’s post hoc test to evaluate the significance of differences for the normal distribution of quantitative characteristics; they used the nonparametric Kruskal–Wallis test with Dunn’s post hoc test for the non-normal one.Results. Dexmedetomidine administration resulted in significant two-hour changes in the rabbit brain, and the authors observed an increase in the delta rhythm and a decrease in the theta rhythm. At equimolar doses, atipamezole returned the ratios of the wave rhythm indices to the baseline values, whereas proroxan had no effect on the ratios.Conclusions. As demonstrated by the neutralisation of dexmedetomidine sedative and hypnotic effects, atipamezole can be used in veterinary for recovery from anaesthesia. Proroxan, on the contrary, is not effective in reversing the sedative effect of dexmedetomidine.

The impact of sleep disorders on the formation and course of cardiovascular diseases. Review

It is well known that several common mechanisms of pathogenesis make the basis of formation of sleep disorders, hypertension, and type 2 diabetes mellitus (DM 2). First of all, one should take into account possible activation of the sympathoadrenal system, which underlies both the pathogenesis of hypertension and always accompane lack of quality sleep. It has been established that markers of systemic inflammation are raised in both chronic sleep disorders and hypertension and DM 2. Another unifying factor is the increase in aldosterone levels, which is characteristic of both sleep disorders and hypertension and DM 2. A number of studies have demonstrated the role of endothelial dysfunction in the development of chronic sleep disorders. Eating disorders, such as eating high‑calorie meals at bedtime, are both a risk factor for diabetes and sleep disorders. Normally, there are circadian rhythms of blood pressure regulation and insulin production and secretion, which can be observed in circadian sleep disorders. An important factor that contributes to the formation of sleep disorders in patients with hypertension and diabetes is the increase in anxiety and depression, which also often accompany both conditions.At the same time, it has not been established which factors exactly cause insomnia development in patients with hypertension and diabetes. Thereare no data on the occurrence of various sleep disorders in this group of patients in the Ukrainian population, the role of stress hormones in formation of chronic sleep disorders hasn’t been investigated. The most important factor from the point of view of a practitioner is the data on the effects of medicinal products for the treatment of hypertension and diabetes on sleep quality. The role of non‑medicinal correction, such as teaching patients the basics of sleep hygiene in the treatment and prevention of sleep disorders, has not been studied.Thus, insomnia can act as both risk factor for hypertension and diabetes mellitus and often accompany them, significantly affecting the quality of life of patients, treatment effectiveness, and prognosis in this group of patients.

ПАТОМОРФОЛОГИЧЕСКИЕ ИССЛЕДОВАНИЯ ОРГАНОВ КРЫС ПРИ ОТРАВЛЕНИИ ЦИАНОПИРЕТРОИДОМ И ИСПОЛЬЗОВАНИИ ЛЕЧЕБНЫХ СРЕДСТВ

Experiments were conducted to study the effect of medicinal products consisting of dipyroxime, sodium bromide, pyridoxine and phenazepam with diosmectite on pathomorphological changes in the internal organs of white rats with β-cypermethrin poisoning in an average lethal dose. The results of the study showed that the most pronounced effect of the pesticide has on the liver, kidneys, and brain. Necrobiological and dystrophic changes were noted. The use of a therapeutic agent consisting of dipyroxime, sodium bromide and pyridoxine leads to a decrease in the negative effect of the pesticide on the liver, brain and kidneys. The use of phenazepam and diosmectite leads to a sedative effect on animals, and promotes the adsorption and excretion of β-cypermethrin from the animal body.

THE METHOD OF FORECASTING AS AN IMPORTANT STAGE IN SOLVING THE PROBLEMS FACING HEALTH IN THE FIELD OF MEDICAL CARE OF THE POPULATION

The aim: Of the work is to investigate and prove the effectiveness of medicinal products of plant origin for the treatment of cardiovascular diseases. Materials and methods: Pharmacoeconomic, social, medical demographic and statistical studies were studied. The study involved cardiologists, pharmacists, consumers of pharmacies and patients of cardiology departments. Results: Forecasting the need for cardiac medicines in general, and in medicinal products of plant origin (MP PO), in particular, is increasing as the population, life expectancy, under the influence of socio-demographic factors, and, most importantly, the increase in the number of elderly people. When solving problems facing public health in the field of drug provision of the population, a regular analysis of the pharmaceutical market and a forecast of the need for medicines in the context of the pharmacotherapeutic group that is being studied are necessary. An important stage in the choice of forecasting methods is the possibility of attracting the required number of indicators, which is a characteristic of the normative method, whose accessibility and simplicity make it possible to use it by specialists who do not have special mathematical training at the level of medical and pharmaceutical organizations. Conclusions: Prevention of diseases should be based on the implementation of government programs for prevention and promotion of health. This will improve and actively use methods of early detection of social and economic factors, which is a threat of development of diseases of the cardiovascular system.

Non-antibiotics, Efflux Pumps and Drug Resistance of Gram-negative Rods

Non-antibiotic medicinal products consist of drugs with diverse activity against bacteria. Many non-antibiotics demonstrate direct anti-bacterial activity against Gram-positive cocci. The activity observed against Gram-negative rods is much lower and non-antibiotics primarily from the following groups: non-steroidal anti-inflammatory drugs, cardiovascular and antidepressant medicinal products demonstrate this activity. It has been shown that the low activity of some non-antibiotics or the absence of activity against Gram-negative rods is related, among other things, to the extrusion of these compounds from bacterial cells by multi-drug resistance efflux pumps. Substrates for the resistance-nodulation-division efflux systems include the following non-antibiotics: salicylate, diclofenac, ibuprofen, mefenamic acid, naproxen, amitriptyline, alendronate sodium, nicergoline, and ticlopidine. In addition, interactions between non-antibiotics and multi-drug resistance efflux pumps have been observed. It has also been revealed that depending on the concentration, salicylate induces expression of multi-drug resistance efflux pumps in Escherichia coli, Salmonella enterica subsp. enterica serotype Typhimurium, and Burkholderia cenocepacia. However, salicylate does not affect the expression of the resistance-nodulation-division efflux systems in Stenotrophomonas maltophilia and Acinetobacter baumannii. Most importantly, there were no effects of medicinal products containing some non-antibiotic active substances, except salicylate, as substrates of multi-drug resistance efflux pumps, on the induction of Gram-negative rod resistance to quinolones.

Key Changes in Benefit–Risk Assessment Guidelines and Implications for Data Analysis in Drug Development

ABSTRACTThe number and complexity of regulatory and legislative policy initiatives for benefit–risk (B-R) assessments and the challenges associated with operationalizing and integrating these initiatives in the drug development process have increased exponentially in the last 10 years. Although there are some similarities in the approaches being used among regions, there are no unifying principles for a consistent approach to address various regulatory agency requirements. Therefore, some sponsors might end up with marketing authorization in one region but not in another, in spite of using the same available benefits and risks evidence without obvious differences between regions. Fortunately, however, there has been a recent global effort by the International Conference on Harmonization (ICH) to develop guidance which provides greater specificity on the format and structure of B-R evidence that is submitted with marketing applications in Module 2 of the Common Technical Document (CTD). The guidance was finalized in June 2016.This article highlights some of the more notable proposed revisions to the ICH guidance for the B-R conclusions (Section 2.5.6) that was recently made public and some germane points to consider, particularly as it relates to effort to minimizing uncertainties associated with the B-R assessment. The discussion speaks to the dynamic nature and attendant imbalances between the pre- and post-market settings in the sources, timing and nature of the information we collect on favorable (benefits) and unfavorable (risks) effects of medicinal products, characterization of these products' attributes including the emerging role of patient input in product development, and the need to better integrate clinical trial findings and real-world clinical data to enhance our understanding of the expected performance of medical products in the intended patient population.

Intoxication with a tropenol ester

While the effects of medicinal products are investigated in depth before approval, often very little is known about the intermediates occurring during synthesis. The pharmacological properties of these intermediates can differ substantially from those of the end product. To describe a work accident involving intoxication with such an intermediate, tropenol ester. A healthy 40-year-old chemical-technical operative erroneously used a scrubbing brush that had just been used to clear up tropenol ester, contaminating his work clothes. Presumably, contact was made with his skin when removing his work clothes later. Shortly thereafter, he developed signs of anticholinergic intoxication with mydriasis, dry mouth, abnormal coordination and later sleepiness and seizures. The patient received intensive medical treatment. Two weeks later, the anticholinergic symptoms had subsided. Qualitative analysis of a urine sample showed traces of tropenol ester. The substance is a muscarinic acetylcholine receptor antagonist. The clinical symptoms and biomonitoring suggest that intoxication with tropenol ester had occurred, which, as a tertiary amine, readily passes through the blood-brain barrier. The protracted course suggests high affinity for the receptor. Appropriate safety precautions must be taken when handling research substances and intermediates of unknown toxicity.

Laboratory diagnostics of pheochromocytoma

Biochemical diagnosis of pheochromocytoma is based on the measurement of altered levels of normetanephrine and metanephrine in plasma or 24-hour urine samples. Plasma normetanephrine and metanephrine levels four times the upper limit of the normal value or metanephrine and normetanephrine excretion in urine above 700 and 1500 mcg/24 hours respectively makes further testing unnecessary and subsequent examination must be focused on the determination of tumour localization. In patients presenting with the above parameters elevated within the "grey zone", effect of medicinal products needs to be excluded and the diagnosis confirmed in the clonidine test or by the measurement of chromogranin A level.

Das Arzneibuch

The pharmacopoeia is an official collection of approved pharmaceutical standards. In addressing anyone who produces, distributes or controls medicinal products it comprises requirements on the quality of medicinal products and of the substances used to manufacture them. Moreover, it provides quality control methods. It is therefore an important component of the drug safety system and thus an instrument for patient and consumer protection. How ever, the trend to outsource the production of raw materials to countries outside Europe is often associated with altered production procedures and may have severe consequences. Unwanted side effects of medicinal products--caused by quality changes of the raw materials--may occur. However, this peril can be significantly reduced by consistently adapting the provisions of the pharmacopoeia to the evolution of the drug market.

Weight and consequences of post-marketing (-approval) experience

In the European Union the term pharmacovigilance is normally used to describe post-marketing or, more precisely, post-approval experience after the regulatory approval of drugs and their introduction to the market...

Drug Safety in the European Community

By 1992 the European Community's pharmaceutical legislation will cover all industrially produced medicines, including vaccines, blood products and radiopharmaceuticals. The quality, safety and efficacy requirements have been harmonised, as have certain aspects of procedures for marketing authorisation or for manufacture. The complete texts of the 'Rules Governing Medicinal Products in the European Community' were published recently. Pharmaceutical companies have 2 types of European Community registration procedures available, which are intended to facilitate the adoption of a common position by the member states. The experience gained with the procedures of the Committee for Proprietary Medicinal Products (CPMP) has highlighted opportunities for closer cooperation, either before national decisions (concertation procedure) or after such decisions (multi-state procedure). The installation, in 1993, of a single European market without borders implies that medicinal products should be able to circulate throughout the European Community with the same conditions attached to their marketing. Monitoring the adverse effects of medicinal products (pharmacovigilance) is also a major issue. The existing arrangements for exchanging postmarketing information will be reinforced, in future, by strengthening the legal provisions already in force.