Session I / Sesja I | 14:10–16:00
Traditional and Complementary Therapies: Regulatory and Clinical Perspectives
Terapie tradycyjne i komplementarne: perspektywy regulacyjne i kliniczne
14.10 - 14.30
Vitalijus Naumavicius, MD, PhD
Department of Holistic Medicine and Rehabilitation, Faculty of Health Sciences, Klaipeda University, Klaipėda, Lithuania
Integrating Traditional Chinese Medicine into clinical decision-making: challenges for patient safety
Włączanie tradycyjnej medycyny chińskiej do procesu podejmowania decyzji klinicznych: wyzwania dla bezpieczeństwa pacjenta
(Patient safety amidst the diversity of therapeutic methods: the intersection of legal regulation and clinical individualization)
Language / Język: English / angielski
Background:
In modern medicine, patient safety remains a paramount goal. With the expansion of therapeutic pluralism, the integration of complementary and alternative medicine (CAM) methods into official healthcare practice necessitates a comprehensive re-evaluation of safety criteria for these services. Objective: To demonstrate that CAM methodologies are being actively integrated into contemporary healthcare and to highlight that patient safety is not solely a legal concept, but also has important biological and clinical dimensions that require continuous assessment of individual patient characteristics and therapeutic responses.
Methods:
An analysis of the legal framework (specifically, the Law on Complementary and Alternative Healthcare of the Republic of Lithuania) and a theoretical review of biological and clinical principles (genetic polymorphism, systemic organismic response).
Results:
1. Formal Level: In Lithuania, CAM safety has been systematically addressed since 2021 through the standardization of specialist training, licensing, and facility requirements. This framework ensures safe technical and physical conditions for procedures (e.g., acupuncture).
Fundamental Level: Patient safety does not imply a complete absence of biological activity or responses from the organism; rather, it requires a meticulous and continuous evaluation of benefits, potential risks, and individual patient characteristics. The term "safe" is most accurately applied to chemical preparations or specialized technical equipment. Preparations must correspond to the intended chemical composition, and equipment must generate the prescribed scope of electrical, radiation, ultrasonic, or magnetic load.
Clinical Level: The human body is a semi-open physiological system that is constantly changing while maintaining specific structural parameters. Because the human population is characterized by substantial interindividual variability—including genetic, physiological, and environmental differences—standardized treatment protocols may not achieve optimal outcomes for all patients. In some cases, individual responses to treatment may vary considerably, highlighting the importance of ongoing clinical assessment and personalized decision-making.
Conclusions:
Standardized protocol-based treatment remains an essential component of modern healthcare and is particularly effective in emergency, acute, and military medicine settings.
When the therapeutic goal is to restore the quality of life, manage chronic pain, or regulate autonomic reactivity, an individualized approach may be especially valuable and effective for selected patients with long-term or chronic conditions.
Patient safety is supported by both evidence-based clinical protocols and the expertise of qualified healthcare professionals who continuously assess patient responses and adapt treatment when clinically appropriate. A comprehensive understanding of different therapeutic approaches may contribute to more informed clinical decision-making and the selection of the most appropriate treatment strategy for individual patients.
Furthermore, ensuring safety relies heavily on transparent communication between patients and healthcare professionals, fostering professional responsibility, and maintaining an integrative overview when conventional and traditional therapies are utilized simultaneously.
Keywords:
patient safety, therapeutic pluralism, complementary medicine, individualized treatment, clinical protocol, interindividual variability.
Aldona Vyšniauskienė, Medvisit Holistic Medical Center, , Vilnius, Lithuania
Integrating Ayurvedic Practice into Clinical Decision-Making: Patient Safety Challenges
Growing demand for integrative medicine means clinicians increasingly encounter Ayurvedic practices—through patient self-use, cultural expectations, and chronic disease management. Ayurveda is a whole-person health system grounded in individual constitution (prakriti) and its deviation (vikriti), aligning naturally with the contemporary need for individualized treatment.
This presentation examines a concrete digital case: optical pulse sensors that compute heart-rate variability (HRV) and report results in Ayurvedic or Traditional Chinese Medicine terms. The central argument is the need to separate two layers: the measurement layer (objective physiological HRV indices) and the interpretive layer (the heuristic translation into “Vata” or “Pitta”). The device does not measure “Vata” the way a thermometer measures temperature.
The talk identifies key patient-safety challenges: diagnostic delay, herb–drug interactions, protection of sensitive health data, and over-claiming. It proposes a model for responsible integration in which Ayurveda functions as a complementary, hypothesis-generating layer with a parallel safety screen, never replacing necessary biomedical diagnosis. The core conclusion: by honestly naming what is measured, what is computed, and what is interpreted, integration becomes safe.
Radosław Gut, MD, PhD,
Homeopathy in contemporary orthopedic practice: evidence, regulation and patient safety
Homeopathy remains one of the controversial therapeutic "complementary methods" used by patients alongside "conventional" treatment, and sometimes instead of it. The presentation concerns homeopathy from an orthopedic surgeon's perspective, taking into account the quality of scientific evidence, legal regulations, and patient safety. To discuss the role of homeopathy in patient care, a distinction between high- and low-potency preparations, and between classical homeopathy and concepts known as low-dose medicine (which, to some extent, share similarities with homeopathy), is required. Each of these categories should be assessed separately in terms of theoretical foundations, quality of scientific evidence, and safety of use.
Selected orthopedic interventions, such as prolotherapy, autologous therapies, and injection-based methods for chronic pain management, which in certain respect demonstrate ontic and praxeological similarities to homeopathy and low-dose medicine, will be described. The use of porcine tropocollagen (Sus scrofa collagen / collagen, porcine), discussed in details as an example, ithe context of low-dose medicine and contemporary debates concerning complementary therapeutic approaches. The strategies and tactics of therapeutic interventions used by homeopaths and orthopedic practitioners will be compared in the context of the "evidence-based medicine" model, which strives to standardize treatment based on scientific research, as well as the need for individualized treatment for each patient. The physician's/surgeon's responsibility for determining the value of "complementary methods" in patient management and setting the limits of their use will be addressed.
Keywords: homeopathy, low-dose medicine, orthopedics, evidence-based medicine, biological treatment, tropocollagen, patient safety.
Łukasz Grotowski, MA
Mechanical Therapies in Clinical Practice: Historical Foundations, Neurophysiology and Implications for Patient Safety
Background: Mechanical therapies are widely used in musculoskeletal care, including physiotherapy, manual therapy, osteopathy, chiropractic practice, and rehabilitation. Traditionally, their rationale was based on biomechanical concepts such as joint dysfunction, segmental restriction, and structural asymmetry. Contemporary pain science has increasingly challenged these explanations and shifted attention toward neurophysiological mechanisms.
Methods: This presentation is based on a narrative review of contemporary literature addressing the historical development of mechanical therapies, mechanisms of manual therapy, pain neurophysiology, and patient safety.
Results: Current evidence suggests that the effects of mechanical therapies are primarily mediated through neurophysiological processes, including mechanotransduction, modulation of sensory input, activation of endogenous pain inhibitory systems, autonomic responses, and neuroplastic adaptations. Their clinical benefits appear to be related more to changes in pain processing, movement behaviour, and perceived threat than to lasting structural correction. Modern safety frameworks emphasize clinical reasoning, risk assessment, informed consent, monitoring of patient responses, and effective communication.
Conclusions: An evidence-informed approach to mechanical therapies requires integration of scientific evidence, clinical expertise, and patient values. Patient safety should be viewed as a multidimensional concept encompassing technical, diagnostic, communicative, and ethical competencies.
Keywords: mechanical therapies; manual therapy; pain neurophysiology; mechanotransduction; patient safety; evidence-based practice.
Dr Anoop AK, PhD, MD, BAMS
Ayurvedic Clinical Practice in Kerala: Challenges, Patient Safety, and Clinical Perspectives
Background: Arya Vaidya Sala (AVS), Kottakkal, one of the largest and oldest Ayurvedic healthcare institutions in Kerala, India, caters to a substantial patient population through its network of hospitals and clinics. The institution records more than 1,500 inpatient (IP) admissions every month and served an outpatient (OP) population of 614,990 patients during the previous year, reflecting its significant role in Ayurvedic healthcare delivery.
Objective: To highlight clinical outcomes of Ayurvedic management in chronic disorders and discuss key challenges and strategies for strengthening patient safety in contemporary Ayurvedic practice in Kerala.
Methods: Clinical observations from retrospective studies conducted at Arya Vaidya Sala, Kottakkal, were reviewed. The studies included 117 patients with ankylosing spondylitis (2020–2024) and 57 patients with multiple sclerosis (2020–2025). Outcomes were assessed using inflammatory markers, pain scores, symptom profiles, and overall clinical improvement. Current practices in quality control, research governance, and pharmacovigilance were also examined.
Results: Significant reductions in pain and inflammatory markers were observed among patients with ankylosing spondylitis following individualized Ayurvedic treatment, including internal medicines, Panchakarma, and Rasayana therapies. In multiple sclerosis, 80% of patients achieved moderate-to-good clinical improvement, with notable reductions in pain, weakness, gait disturbances, and sensory symptoms. Quality assurance measures such as raw material authentication, standardization, GMP compliance, and adverse event monitoring were identified as essential contributors to patient safety and treatment reliability.
Conclusion: Ayurvedic interventions demonstrated promising clinical outcomes in chronic inflammatory and neurodegenerative disorders. Strengthening evidence generation, translational research, pharmacovigilance, standardized protocols, and quality assurance systems is essential to enhance patient safety and support the integration of Ayurveda into modern healthcare frameworks.
Keywords: Ayurveda in Kerala, Ankylosing Spondylitis, Multiple Sclerosis, Panchakarma, Pharmacovigilance, Quality Assurance.
Piotr Kalan, MBBS, FRACGP
Access to Medicines in Australia: Regulation, Availability and Patient Safety
Background: Access to medicines is influenced not only by the availability of pharmaceutical products but also by regulatory frameworks, reimbursement policies, and patient safety mechanisms. Australia has developed a comprehensive system that seeks to balance affordability, access, and safe prescribing practices as well as obtaining specific product instruments, and it technology.
Objective: To present the key institutions and regulatory mechanisms governing access to medicines in Australia, with particular emphasis on the Pharmaceutical Benefits Scheme (PBS), the Therapeutic Goods Administration (TGA), and contemporary approaches to patient safety.
Material and Methods: This presentation is based on the author’s experience as a general practitioner practicing in Australia for over 30 years, supported by an overview of the Australian pharmaceutical regulatory and reimbursement framework.
Results: The Pharmaceutical Benefits Scheme (PBS) is a government-funded program that subsidizes the cost of essential medicines, significantly reducing out-of-pocket expenses for eligible Australian citizens and permanent residents. Additional protections are provided through the PBS Safety Net, which limits annual medication expenditures for patients requiring long-term treatment. The Therapeutic Goods Administration (TGA) serves as Australia’s national regulatory authority responsible for the evaluation, approval, registration, and post-marketing surveillance of medicines, medical devices, and therapeutic products. Through rigorous assessment of safety, quality, and efficacy, the TGA regulates access to new therapies and oversees the reporting of adverse drug reactions of instruments and any other medical products. Patient safety is further strengthened through prescribing restrictions for controlled medicines and the implementation of real-time prescription monitoring systems that assist clinicians in identifying potential medication misuse, doctor shopping, and overdose risks.
Conclusions: The Australian model demonstrates how public funding, regulatory oversight, and electronic monitoring systems can work together to ensure equitable access to medicines while maintaining high standards of patient safety. The combined roles of PBS and TGA provide an example of an integrated approach to pharmaceutical governance that balances affordability, innovation, and responsible prescribing.
Keywords: patient safety; access to medicines; pharmaceutical governance; PBS; TGA; medication safety; prescription monitoring; Australia.
Marta Zayats PhD
Pharmacotherapy and patient safety in tactical medicine
Background. The foundation of a tactical medicine – The Tactical Combat Casualty Care (TCCC) protocol, had unfortunately become more relevant due to the war in Ukraine. These principles apply not only on the battlefield, but also in cities behind the front lines in Ukraine. In modern tactical medicine, the primary goal is not only to ensure the survival of the wounded and the rescuer’s own safety, but also to guarantee the safety of pharmacotherapy.
Methods: content analysis, comparative analysis, systematization, and scientifically summarizing sources.
Results. The addition of medications to tactical medicine had happened gradually and was based on the actual causes of mortality (massive external bleeding, airway obstruction, pneumothorax) and complications due to battlefield conditions.
The TCCC tactical system was developed in the early 1990s, with the first protocols published in 1996, followed by standardization and regular updates since 2002. Prior to the existence of the TCCC protocol, approximately 90% of battle-related deaths occurred before the wounded person arrived at a medical institution, which is why the first minutes and hours after the injury are critically important.
Pharmacotherapy in TCCC is categorized by access levels, with mandatory safety monitoring: at the ASM(All Service Members)/CLS(Combat Lifesaver) basis level, only simple oral medications are being used (paracetamol, meloxicam, moxifloxacin), while high-risk medications (ketamine, fentanyl, tranexamic acid, and broad-spectrum antibiotics) are available only to combat medics and paramedics. These drugs fall into the category of high-alert medications (according to the ISMP), meaning that if the incorrect dosage, route of administration, or monitoring of the patient’s condition, there is a high risk of serious complications or death.
Conclusions.
1. A tiered system for accessing pharmacotherapy in tactical medicine has been shown to ensure an optimal balance of drug efficacy and safety, reducing the risk of complications and medical errors in the prehospital setting.
2. The protocol-based use of high-alert medications, as defined by ISMP, is essential for minimizing medication errors through control of dosage, route of administration, and patient monitoring. In tactical and field care, administration by appropriately trained personnel may contribute to safer pharmacotherapy and better outcomes for wounded patients.
3. The integration of pharmacological interventions with the mechanical methods of TCCC reflects a systematic approach to patient safety, supports the evidence-based validity of protocol-defined therapy, and allows adaptation of interventions to the specific conditions of both battlefield and rear environments.
Keywords: patient safety, tactical medicine, TCCC, pharmacotherapy, high-alert drugs, ISMP, life safety.
Joanna Zawitkowska, MD, PhD, DSc, Associate Professor
Department of Pediatric Hematology, Oncology and Transplantology, Medical University of Lublin, University Children's Hospital in Lublin, Poland
Pediatric patient safety in the AI Era: personalization of treatment and communication with parents of children with hematological cancers
Language / Język: Polish / polski
Pediatric hematology is entering a period of exceptional transformation. On the one hand, we have increasingly precise tools for personalizing treatment for hematological malignancies—from advanced molecular diagnostics to targeted therapies and immunotherapy. On the other hand, we are witnessing the dynamic development of artificial intelligence technology, which is beginning to have a real impact on clinical decision-making and how parents seek, interpret, and understand information about their child's health. Parents eagerly acquire information about their child's disease and the diagnostic and therapeutic process using AI tools. Sometimes, they even present ready-made therapeutic solutions to doctors, demanding their use. The common goal is the child's safety. Therefore, doctors face challenges related to implementing modern therapies in collaboration with parents to ensure their child's safety.
Alicja Widz, 5th-Year Pharmacy Student, Medical University of Lublin, Poland
Member of the Medical Humanities Student Scientific Association at the Department of Humanities and Social Medicine
Ayurvedic medicinal plants in the supportive treatment of depression: clinical and patient safety perspectives
Depression remains one of the leading causes of disability worldwide, with a substantial proportion of patients inadequately responding to conventional pharmacotherapy or experiencing significant adverse effects. Growing interest in complementary and integrative medicine has directed scientific attention toward Ayurvedic medicinal plants as potential adjunctive agents in the management of depressive disorders. This review examines the clinical evidence and patient safety profiles of key botanicals employed in the Ayurvedic tradition —including Withania somnifera (ashwagandha), Bacopa monnieri (brahmi), Centella asiatica
(gotu kola), and Curcuma longa (turmeric) — with particular emphasis on their putative mechanisms of action in the context of mood regulation. Preclinical and clinical data suggest that these plants may exert antidepressant effects through modulation of the hypothalamic-pituitary-adrenal (HPA) axis, serotonergic and dopaminergic neurotransmission, neuroinflammatory cascades, and oxidative stress pathways. Withania somnifera demonstrates adaptogenic and anxiolytic properties linked to cortisol attenuation and GABAergic activity. Bacopa monnieri appears to influence monoamine metabolism and neuronal plasticity, with evidence supporting improvements in mood and cognitive function in affective disorders. Centella may modulate monoaminergic neurotransmission and reduce
neuroinflammatory activity, while Curcuma longa — primarily through its active constituent curcumin — exerts well-documented anti-inflammatory and neuroprotective effects, including inhibition of pro-inflammatory cytokines implicated in the pathophysiology of depression. Randomized controlled trials have demonstrated improvements in depressive symptoms for selected Ayurvedic preparations, particularly ashwagandha and curcumin-containing formulations.
However, critical safety considerations must be addressed prior to clinical integration. Concerns include potential herb-drug interactions with antidepressants, anticoagulants, and immunosuppressants — particularly relevant for Curcumin may interact with drugs metabolized by cytochrome P450 enzymes, although the clinical relevance of these interactions remains incompletely understood. Additional risks encompass gastrointestinal adverse effects at higher doses, variability in phytochemical standardization across commercial preparations, limited safety data regarding use during pregnancy and in certain hormone-sensitive conditions,
and the paucity of long-term safety data across all four botanicals. This review advocates for a rigorous evidence-based framework governing the use of Ayurvedic botanicals in supportive depression care, emphasizing the necessity of structured pharmacovigilance, patient disclosure to treating clinicians, and standardized extract quality. Future large-scale, double-blind, placebo-controlled trials with robust safety monitoring are warranted to establish definitive
recommendations for clinical practice.
Keywords: Ayurveda, medicinal plants, depression, adaptogeny, phytotherapy, herb-drug interactions, patient safety, integrative psychiatry, Withania somnifera, Bacopa monnier
Patrycja Kościńska, 4th-year Dental Medicine Student, Medical University of Lublin, Poland
Artificial Intelligence in Dentistry – Patient Safety Enhancement or New Risks Occurrence
Opiekunowie: dr n. o zdr. i n. med. Katarzyna Szczekala, dr n. hum. Julia Nikiel
Artificial Intelligence (AI) is transforming modern dentistry. The aim of the work is to present its application in safe patient management and potential risks. AI-based programs are improving diagnostic accuracy, treatment planning and clinical efficacy in radiographic analysis, diagnostic dentistry, orthodontics, implant dentistry, prosthodontic design and more. These tools can support clinicians in the reduction of chairside time, improvement of workflow organisation and early disease detection.
Despite these advantages, the implementation of AI in dentistry raises ethical and clinical concerns. The risks include insufficient validation on diverse patient populations, algorithmic bias, data privacy issues, and overreliance on AI. These limitations may negatively affect clinical decision-making; thus, negatively influence treatment planning.
Although current evidence suggests that explainable AI (XAI) models are essential for ensuring patient safety and more effective patient management, AI implementation requires cautiousness and responsiveness. AI accuracy and credibility in dentistry requires close interdisciplinary collaboration of clinicians, researchers, engineers, and regulatory institutions to develop reliable standards ensuring the safety and quality of AI-based medical programs.
Key words: patient safety, risks, dentistry, artificial intelligence, collaboration
Kacper Zając, 4th-Year Dental student, Medical University of Lublin, Poland
Chair of the Students Scientific Association of Medical Communication at the Department of Foreign Languages
Lecture Title / Tytuł wykładu:
Patient safety in therapeutic pluralism and other aspects of dental treatment
Bezpieczeństwo pacjenta w kontekście pluralizmu terapeutycznego i wybranych aspektów terapii stomatologicznej
Scientific Supervisor / Opiekun naukowy: Katarzyna Karska, PhD, Katarzyna Szczekala, PhD
Language / Język: English / angielski
Background: Patient safety is a fundamental element of modern dental care and is closely linked to the quality and effectiveness of treatment. In recent years, therapeutic pluralism has gained increasing importance. It encompasses standard dental procedures based on scientific evidence, as well as complementary methods that can provide a valuable complement to modern dental treatment.
Objectives;To present the importance of patient safety in the context of the application of therapeutic pluralism in dental treatment in selected aspects.
Assumptions: Respect for the patient's right to choose treatment; legal regulations, consent, and responsibility. Proper communication between the patient and the dentist; psychological safety. A review of the most commonly used therapies supporting dental treatment. Infection control and pain control as a safety element.The role of the patient and education in ensuring safety during the treatment process.
Summary: Therapeutic pluralism can be a valuable complement to modern dental treatment, provided that the basis of therapy remains safe, effective, and consistent with current medical knowledge. The most important goal of all therapeutic activities is to ensure patient safety and high-quality dental care.
Keywords: Patient safety; dental care; therapeutic pluralism; complementary therapies; Informed consent; infection prevention
Aleksandra Kusaj, 4th-Year Medical Student, Medical University of Lublin, Poland
Member of the Students Scientific Association of Medical Communication at the Department of Foreign Languages
Gentle and effective communication and clinical approach in pediatric and adolescent gynecology
Delikatnie i skutecznie: komunikacja oraz postępowanie kliniczne w ginekologii dziecięcej i młodzieżowej
Scientific Supervisor / Opiekun naukowy: Katarzyna Szczekala, PhD; Katarzyna Karska, PhD
Language / Język: Polish / polski
Hospitalization, surgical interventions, and even doctor visits for underage patients can be traumatic due to emotional immaturity and the anxiety associated with new experiences. In the case of gynecological procedures, improper treatment of the patient can lead to a decline in self-esteem and trust in healthcare professionals. A fear of visiting a gynecologist in adolescence may stem from the immaturity inherent in this stage of development, a lack of knowledge of one's own anatomy, and a fear of intrusion. Gynecologists treating underage patients should exercise particular caution and empathy during the interview and physical examination. Considering the patient's age, the educational aspect of doctor visits should be considered, using language appropriate to the patient's perception. It is essential to ensure privacy, while actively involving parents or legal guardians in the diagnostic process. Optimal treatment in pediatric gynecology should not be limited solely to curing the underlying organic disease. Patient safety from a holistic perspective requires the collaboration of interdisciplinary teams (gynecologist, psychologist, pediatrician, endocrinologist), which allows for effective therapy, health promotion, and prevention.
Keywords: trauma, pediatric gynecology, patient safety, empathy, health promotion
Filip Jurczyk, 2nd-Year medical student, Medical University of Lublin, Poland
Member of the Medical Humanities Student Scientific Association at the Department of Humanities and Social Medicine
Ethical problems of modern psychopharmacotherapy
Etyczne problemy współczesnej psychofarmakoterapii
Scientific Supervisor / Opiekun naukowy: Agnieszka Polak, PhD
Language / Język: English / angielski
Introduction: Over the past two decades, a sustained increase in the prevalence of mental disorders and the use of psychotropic medications has been observed worldwide. As a result, questions concerning the effectiveness, safety, accessibility, and ethical dimensions of pharmacological treatment have become increasingly important in contemporary psychiatric practice.
Aim: The aim of this presentation is to discuss selected ethical issues and dilemmas associated with the pharmacological treatment of mental disorders.
Materials and Methods: Narrative review of the literature and critical analysis of relevant scientific publications.
Discussion: Alongside psychotherapy, contemporary psychopharmacology constitutes a cornerstone of modern psychiatric treatment. However, the biological interventions associated with psychopharmacotherapy give rise to numerous ethical concerns. At the individual level, these include questions regarding patient autonomy, informed consent, treatment safety, and the potential long-term effects of psychotropic medications on cognitive functioning, personality, and overall physical health. From a systemic perspective, ethical scrutiny should also encompass the influence of pharmaceutical and insurance industries on treatment practices, as well as broader societal models shaping attitudes toward psychopharmacological interventions.
Keywords: psychopharmacotherapy; ethical aspects of treatment; pharmacotherapy safety; mental disorders
Aleksandra Wilkos, 1st-Year Physiotherapy Student, Medical University of Lublin, Poland
Member of the Students Scientific Association of Medical Communication at the Department of Foreign Languages
Patient safety and effectiveness in pain management: combining phytotherapy and physiotherapy
Bezpieczeństwo pacjenta i skuteczność leczenia bólu w terapii łączącej fitoterapię i fizjoterapię
Scientific Supervisor / Opiekun naukowy: Katarzyna Szczekala, PhD
Language / Język: English / angielski
Pain, as one of the most significant factors that reduce quality of life (QoL) and limit mobility along with activities of daily living (ADLs), constitutes one of the most common presenting symptoms in physiotherapy. Chronic pain therapy is associated with frequent and/or long-term use of analgesics along with the risk of adverse effects and addiction to opioids and nonsteroidal anti-inflammatory drugs (NSAIDs); thus, there is a growing interest in less invasive treatment methods. The aim of this paper is to assess the effectiveness and safety of the combination of phytotherapy and physiotherapy in pain management. Selected therapies for patients suffering from pain in musculoskeletal disorders and post-stroke recovery are discussed. The anti-inflammatory and analgesic properties of selected plant materials, such as St. John's wort, meadowsweet, ginger, willow bark, and turmeric, as well as products derived from them, including essential oils, are presented. Bioactive substances in those plants have been demonstrated to reduce pain and the need for conventional medications. However, some risks are highlighted like possible drug interactions, questionable quality of the preparations, and a relatively limited number of studies confirming their actual effects on the human body. The combination of phytotherapy and physiotherapy is a promising, patient-centered pain management strategy that requires further clinical trials to confirm its effectiveness and safety assurance.
Key words: physiotherapy, phytotherapy, effectiveness, patient safety, quality of life, pain management
Maciej Paszkowski, MD, PhD
III Chair and Department of Gynaecology, Faculty of Medicine, Medical University of Lublin, Poland
Clinical trials, pharmaceutical promotion and ethical challenges in patient safety
Badania kliniczne, promocja produktów leczniczych i wyzwania etyczne w bezpieczeństwie pacjenta
Language / Język: Polish / polski
Maciej Paszkowski, MD, PhD, III Chair and Department of Gynaecology, Faculty of Medicine, Medical University, Poland
Clinical trials, pharmaceutical promotion and ethical challenges in patient safety
Badania kliniczne, promocja produktów farmaceutycznych i wyzwania etyczne związane z bezpieczeństwem pacjenta
Background: The process of developing a new drug, from the identification of a potential active substance to its registration and use in clinical practice, takes an average of 10 years and includes numerous stages of preclinical and clinical trials. Only a fraction of tested molecules successfully pass all stages of efficacy and safety assessment. High research costs and a significant risk of failure mean that the development of new therapies is closely linked to the activities of the pharmaceutical industry. The question arises of how to reconcile the need to recover research and development costs with the requirements of independent scientific research, data transparency and the overarching principle of patient safety.
Modern clinical trials are conducted within an extensive regulatory system designed to protect research participants and ensure the reliability of the results obtained. In practice, this means following detailed procedures for informed consent, monitoring adverse events, reporting results and independent oversight of the study. These mechanisms are designed to reduce potential bias in the assessment of efficacy and safety and to strengthen the independence of clinical research. At the same time, the growing commercialisation of healthcare raises important questions about the relationship between scientific evidence, marketing and therapeutic decision-making, particularly regarding the extent to which economic interests may influence clinical research and scientific communication.
At the same time, the market for dietary supplements and various therapies offered outside standard clinical evaluation procedures is experiencing dynamic growth. This situation creates additional challenges related to protecting patients from misinformation and making health decisions based on insufficient scientific evidence. Consequently, inaccurate or misleading health information may contribute to delayed diagnosis, inappropriate treatment choices or the use of interventions lacking adequate evidence of efficacy and safety.
Aim The aim of the presentation is to critically analyze contemporary legal and ethical mechanisms for patient protection and to discuss the challenges related to the commercialization of medicine, health disinformation and the use of therapies that are insufficiently scientifically verified. The presentation aims to demonstrate the importance of contemporary regulations in ensuring therapeutic safety and protecting public health.
Conclusions
Patient safety is not a feature of a single drug or the result of the actions of a single institution. It is the result of a multi-stage process encompassing scientific research, legal regulations, oversight of medicinal products, professional responsibility, and public health education. Effective patient protection requires both high standards of therapy evaluation and limiting the impact of misinformation and unproven health practices.
Keywords: clinical research; patient safety; drug promotion; medical ethics; health misinformation; therapeutic decision-making
Marta Monist, MD, PhD
II Chair and Department of Gynaecology, Faculty of Medicine, Medical University of Lublin, Lublin, Poland
Human papillomavirus (HPV) in adults: prevention, diagnosis, and public health perspectives
Wirus brodawczaka ludzkiego (HPV) u osób dorosłych: profilaktyka, diagnostyka i wyzwania zdrowia publicznego
Language / Język: Polish / polski
Human papillomavirus (HPV) infections are among the most common sexually transmitted infections and have been a topic of interest to clinicians, epidemiologists, and public health specialists for many years. At the same time, HPV prevention remains a topic of public debate. Alongside positions emphasizing the importance of vaccinations and screening, there are also voices pointing to the role of health education, responsible sexual behavior, educating adolescents, and building health literacy as fundamental elements of prevention. Issues of vaccine safety, the long-term effectiveness of prevention programs, patient autonomy, and trust in medical and public health institutions are also addressed in public debate.
This presentation will present the HPV problem from the perspective of a gynecologist utilizing the principles of evidence-based medicine (EBM) in daily clinical practice. Particular attention will be paid to a critical analysis of the available scientific evidence, its limitations, and methods for engaging in dialogue with patients who express concerns or present differing views. Current options for the prevention and diagnosis of HPV infections will be discussed, as well as the challenges related to risk communication, shared therapeutic decision-making, and building trust in the doctor-patient relationship.
The aim of this lecture is to demonstrate that effective HPV prevention requires not only medical interventions, but also education, social responsibility, and open and honest conversation about the benefits, limitations, and uncertainties inherent in medicine.
Key words: human papillomavirus; cervical cancer; HPV vaccination; cervical screening; evidence-based medicine; risk communication; shared decision-making; patient safety
Kinga Rutkowska, MSc Pharm
Department of Pharmacology and Clinical Pharmacology, Faculty of Medicine, Cardinal Stefan Wyszyński University in Warsaw, Poland
Bias in clinical trials: are our drug safety assumptions truly evidence-based?
Błędy systematyczne w badaniach klinicznych, czy nasze założenia dotyczące bezpieczeństwa leków są rzeczywiście oparte na dowodach naukowych?
Language / Język: Polish / polski
Randomized clinical trials are regarded as the foundation of evidence-based medicine, yet the evidence they generate is not free from systematic distortion. This presentation examines how multiple forms of bias operating across the clinical research pathway may weaken the validity, generalizability, and ethical credibility of conclusions about drug efficacy and safety. The problem begins with limited representativeness, as only a small proportion of the target population participates in trials. Geographic inequities, restricted access to research centers, armed conflicts, and poor infrastructure all contribute to the exclusion of vulnerable and underrepresented populations. Additional distortions arise from differences in lifestyle, comorbidities, standard of care, access to advanced therapies, and biogeographical ancestry, including pharmacogenetic variability that may influence adverse drug reactions and treatment response.
The presentation further highlights bias related to sex, age, race, literacy, language, diagnosis, study design, sponsorship, publication, outcome measurement, and long-term follow-up. Historical and contemporary examples illustrate how ethical double standards, selective reporting, inadequate informed consent, and commercially driven research agendas can shape both what is studied and how results are interpreted. The phenomenon of fading reported effectiveness over time, along with publication bias and the underreporting of negative or inconclusive findings, raises important questions about the stability of accepted medical evidence. Broader influences such as politics, public opinion, media narratives, and funding structures also affect research priorities and the social reception of medical interventions.
Taken together, these issues suggest that assumptions about drug safety and effectiveness may be more contingent than evidence-based medicine often acknowledges. Recognizing bias as a multidimensional and persistent feature of clinical research is essential for improving trial design, ethical oversight, inclusiveness, transparency, and interpretation of results. A more critical approach to clinical evidence is necessary if research is to serve not only regulatory approval, but also the real needs of diverse patient populations.
Olga Boretska, PhD
Department of Clinical Pharmacy and Pharmacoeconomics, Independent Public Clinical Hospital No. 4 in Lublin, Poland
Medication Adherence as a factor in the effectiveness and safety of pharmacotherapy
Przestrzeganie zaleceń czynnikiem skuteczności i bezpieczeństwa farmakoterapii
Language / Język: Polish / polski
Background. Medication adherence is an important public health issue, while nonadherence is associated with significant economic costs and is estimated to account for about 8% of global health care expenditures. Poor adherence is associated with 200 000 deaths and 125 billion EUR in avoided medical costs per year in Europe and 100 billion USD in the United States annually.
Poor adherence can lead to negative outcomes for patients, including disease progression, increased morbidity, reduced quality of life, higher rates of hospitalization, rising healthcare costs, and mortality. Thus, nonadherence to medication regimens is associated with adverse clinical and economic consequences across various fields of medicine.
Methods: comparative analysis, systematization, and scientifically summarizing sources.
Results. According to estimates by the World Health Organization, only 50% of patients taking medication for chronic conditions adhere to their treatment regimen. Many patients stop taking their medication in the first few months after starting the treatment, often without informing their doctor. Some of those who continue taking their medications do not do so consistently as prescribed. Thus, low adherence may lead to unwarranted dose increases or the prescription of additional medications, increasing the risk of side effects. The number of self-administered treatments is also rising, making improved adherence even more important.
The WHO states: “Increasing the effectiveness of adherence interventions may have a far greater impact on the health of the population than any improvement in specific medical treatments”. However, medication nonadherence is a complex problem influenced by many factors, including barriers related to patients, medications, the disease, and the healthcare system, as well as socioeconomic factors. In summary, methods for improving medication adherence are labor-intensive, time-consuming, and require collaboration with the patient throughout the course of their treatment. Patient-specific (personalized) interventions address both intentional and unintentional causes of nonadherence, including various reminders, adherence packaging, digital technologies, access to reliable and useful medical information, and improved interaction and engagement between healthcare providers and patients.
Therefore, improving adherence is crucial for improving patient treatment outcomes and reducing avoidable use of healthcare resources.
Conclusions. Medication adherence is a factor influencing the outcomes of pharmacotherapy. Good adherence contributes to improved treatment efficacy and safety, underscoring the importance of assessing and supporting it as an integral part of modern clinical practice.
Keywords: medication adherence, safety pharmacotherapy, clinical outcomes.
Rafał Patryn, PhD, DSc; Jolanta Pacian, PhD, DSc; Krzysztof Szostak, Trainee Attorney-at-Law
Unit of Medical and Pharmaceutical Law, Faculty of Medical Sciences, Medical University of Lublin, Poland/ Regional Chamber of Attorneys-at-Law in Lublin, Poland
Patient safety in the context of current legal regulations
Prawne uwarunkowania bezpieczeństwa pacjenta we współczesnym systemie ochrony zdrowia
Language / Język: Polish / polski
Background
Patient safety is one of the key elements of modern healthcare systems. It should be emphasized that it is a multidimensional issue, depending on many factors, including organizational, legal and social ones. Along with the growing public awareness, the importance of legal regulations aimed at improving the quality of healthcare services, strengthening the protection of patients’ rights, and reducing the risk of adverse events has also increased.
Aim
The aim of this paper is to discuss the issue of patient safety in the light of the current legal regulations in force in Poland and the impact of international regulations on patient safety. The focus of the analysis is on identifying the legal instruments that guarantee patient safety, particularly those related to the identification and reduction of medical risk, the obligations of healthcare providers, legal requirements ensuring a high quality of healthcare services, adverse event reporting systems, and liability mechanisms associated with violations of safety standards.
The issue of patient safety was analysed on the basis of legal regulations currently in force in Poland, as well as international standards and regulations in this field.
Conclusions
In conclusion, ensuring effective patient safety requires not only the establishment of appropriate legal regulations, but also their proper implementation and the prevention of adverse events through the analysis of such events. Patient safety does not depend solely on the actions of individual healthcare professionals, but is the result of cooperation among all participants involved in the process of providing healthcare services, as well as the proper organization of healthcare institutions.
The conclusions drawn from this analysis may provide a basis for further discussion on the directions of development of medical law and the role of legal regulations in shaping a safe and effective healthcare system.
Keywords: patient safety, medical law, quality in healthcare, adverse events, patients’ rights, medical liability, safety culture, healthcare.
Rafał Jakub Pastwa, PhD, DSc
Institute of Journalism and Management, John Paul II Catholic University of Lublin (KUL), Lublin, Poland
Between evidence and vulnerability: animal suffering, somatic sympathy and the anthropocentric limits of patient safety in media and clinical practice
Między dowodami a podatnością na cierpienie: cierpienie zwierząt, współodczuwanie somatyczne i antropocentryczne granice bezpieczeństwa pacjenta w mediach i praktyce klinicznej
Language / Język: Polish / polski
Contemporary understandings of patient safety, developed within the framework of Evidence-Based Medicine (EBM), are grounded in the rationalization of risk and the maximization of therapeutic effectiveness for human beings. While epistemologically sophisticated, this model remains structurally anthropocentric. Safety is defined exclusively in relation to the human patient, whereas the conditions under which such safety is produced—including the use of animals in biomedical research and systems of production—remain largely outside the primary scope of ethical reflection. In this sense, patient safety functions as a selective category: it minimizes the suffering of some while systematically overlooking the suffering of other living beings.
Analyses developed within the framework of Critical Human-Animal and Media Studies (CHAMS) demonstrate that this situation is not merely the consequence of scientific or regulatory decisions but rather the result of a broader cultural configuration in which the media play a central role. Media actively participate in constructing and reinforcing an anthropocentric worldview in which animals are represented primarily as resources, instruments, or background elements of human activity. Informational, entertainment, and advertising content systematically reduce animals to their utility, thereby strengthening social justifications for their exploitation. Consequently, animal suffering is symbolically neutralized, while anthropocentric patterns of perception are reproduced as self-evident and “natural.”
Within this context, patient safety emerges as the product of a system that not only manages risk but also selectively determines whose lives and whose suffering deserve protection. Media perform not merely a transmissive but also a normative function: they shape moral sensibilities, define the boundaries of empathy and compassion, and thereby indirectly influence the acceptability of specific biomedical practices. Anthropocentrism is therefore not simply a philosophical position but a communicative practice continuously reproduced through everyday cultural narratives.
The philosophical foundations of this exclusion can be found within the ontological tradition, particularly in the thought of Martin Heidegger, who characterizes the animal as a being that is “poor in world” (weltarm). In this perspective, the animal is deprived of full access to Being, which contributes to its marginalization as a subject of experience. However, as deconstructive analyses have demonstrated, the animal cannot be unequivocally classified either as a thing or as a subject in the human sense. Rather, it occupies a liminal position that destabilizes anthropocentric hierarchies. This ambiguity opens a space for rethinking ethical relations beyond traditional human-centered frameworks.
Reflections developed by Jacques Derrida and reinterpretations of Emmanuel Levinas shift attention away from the question of the animal’s cognitive capacities toward the question of its capacity to suffer. The animal, understood as the “absolute Other,” is no longer merely an object of knowledge but becomes a vulnerable subject whose exposure calls for responsibility. Ethics thus ceases to be exclusively the domain of rational justification and becomes a response to experiences of fragility, dependence, and vulnerability.
At this point, the category of somatic sympathy, developed by Ralph R. Acampora and further elaborated in your own work as a foundation for a universal ethics, becomes particularly significant. Somatic sympathy denotes a profound, embodied form of responsiveness rooted in the experience of the living body—a body capable of pain, suffering, injury, and vulnerability. It is neither empathy in the psychological sense nor a moral norm derived from rational principles. Rather, it is a pre-reflective sensitivity that precedes ontological and epistemological distinctions. Within this framework, somatic sympathy performs a dual function: it serves simultaneously as a mode of knowing—knowledge through embodied co-suffering—and as the basis of ethical obligation, requiring no prior rational or metaphysical legitimation.
Importantly, somatic sympathy also possesses a distinct media dimension. Its absence from communicative practices contributes to the reproduction of indifference toward the suffering of other beings, whereas its presence could foster processes of identification and interspecies solidarity. In other words, media do not simply represent reality; they actively shape the conditions under which compassion and moral concern become possible—or impossible. For this reason, any critique of anthropocentrism must necessarily include an analysis of communicative practices and media representations.
This raises the question of whether transformation is possible. If media contribute to the construction of the anthropocentric paradigm, they may also participate in its transformation. The first step would involve moving beyond representations that portray animals solely in terms of utility and incorporating perspectives that foreground their vulnerability and embodied existence—not through anthropomorphism, but through recognition of their capacity to suffer. A second step would involve developing narratives that reveal the hidden interdependencies between human well-being and animal suffering, particularly within biomedical and industrial contexts. A third step would be the incorporation of concepts such as somatic sympathy into media education and public discourse, thereby encouraging the development of a more inclusive ethical sensibility.
From an institutional perspective, such a shift would also require an expansion of the language of bioethics and health policy. Patient safety could then be reconsidered not merely as the protection of the human patient but as part of a broader system of responsibility for life in its various forms. This does not imply abandoning the achievements of EBM; rather, it calls for complementing them with a deeper awareness of vulnerability, embodiment, and interdependence.
Ultimately, this perspective leads to a fundamental question: Can patient safety be considered ethically adequate if it rests upon the systematic exclusion of the suffering of other living beings? Addressing this question requires moving beyond a narrowly conceived evidential rationality and opening ethical reflection to the experience of shared corporeal vulnerability. In this sense, patient safety, when detached from reflection on the status of animals and the role of media in shaping such reflection, remains an incomplete category—both epistemologically and ethically.
Anita Majchrowska, PhD
Department of Humanities and Social Medicine, Medical University of Lublin, Lublin, Poland
Pharmacotherapy safety as a basic pharmaceutical task in public opinion research
Bezpieczeństwo farmakoterapii jako podstawowe zadanie farmaceuty w badaniach opinii społecznej
Language / Język: Polish / polski
Bacground: Pharmacovigilance is a key aspect of healthcare quality, and pharmacists, as specialists in pharmacology and pharmacotherapy, play a fundamental role in ensuring it. Modern pharmacy practice extends far beyond traditional medication dispensing, encompassing educational activities, monitoring the use of medicinal products, identifying potential interactions, and responding to adverse drug reactions. However, the full implementation of these activities requires the trust that potential patients place in their pharmacists.
Research Objective: The aim of the study was to determine social expectations of pharmacists, whether potential pharmacy patients are willing to use pharmaceutical services, and what forms of assistance they consider important.
Methodology: The survey was conducted on a representative sample of the adult population of Poland. The sample was randomly selected, ensuring representativeness for characteristics such as gender, age, education level, and place of residence.
Results: The most frequently expressed expectation of pharmacists is that they primarily ensure the safety of medications (51.7%). Nearly half of respondents (48.5%) expect pharmacy staff to help manage minor ailments. Approximately one-third (36.3%) of respondents emphasized the role of pharmacists in providing systematic consultations and counseling and in reducing treatment costs (35.8%). 26.8% of Poles expect free tests and 21.7% expect reduced side effects of medications. The smallest percentage of Poles see pharmacists as helping people change their lifestyle towards a healthy one (7.5%).
Conclusions: Poles, appreciating the competence of pharmacists working in pharmacies, expect them to perform their primary role: ensuring the safety of pharmacotherapy.
Keywords: public opinion, pharmacist, pharmacotherapy safety
Renata Bogusz, PhD
Department of Humanities and Social Medicine, Medical University of Lublin, Lublin, Poland
Physician and pharmacist – an (un)obvious tandem: interprofessional collaboration as the key to optimizing pharmacotherapy and effective treatment
Lekarz i farmaceuta, (nie)oczywisty duet: współpraca międzyzawodowa kluczem do optymalizacji farmakoterapii i skutecznego leczenia
Language / Język: Polish / polski
Background: One of the pillars of a well-functioning healthcare system is the effective collaboration of an interprofessional therapeutic team. This statement should clearly apply to relationships between representatives of all professional groups, for whom caring for the life, health, and safety of patients is a priority. However, for many years, the potential of Polish pharmacists was not adequately utilized, and their relationships with physicians were characterized primarily by isolation and one-way, formal communication. Dynamic legislative, technological, and social changes (particularly the implementation of the Pharmacists' Profession Act and the consequences of the COVID-19 pandemic) have created new opportunities for strengthening cooperation and truly involving pharmacists in disease prevention and treatment activities.
Aim: To identify and analyze the currently dominant models of professional relationships between physicians and pharmacists in Poland in the face of intense systemic changes and the experiences resulting from the COVID-19 pandemic. Material and Methods: The study was conducted among representatives of two professional groups (335 pharmacists and 233 physicians) after the end of the COVID-19 pandemic, using a nationwide, anonymous diagnostic survey using a proprietary questionnaire. The research tool was based on theoretical models previously described in the literature, distinguishing a continuum of nine relationships: from complete isolation to full professional integration at the individual and institutional levels. Results: The highest percentage of responses was given to the mutual model (occasional collaboration, as needed, initiated by a physician or pharmacist) (35.2% of physicians and 29.6% of pharmacists). Exceptional symmetry was noted in the "stereotypical perception" category (20.9% of pharmacists and 20.6% of physicians). A strong, statistically significant relationship was found between profession and the assessment of the relationship model. A clear asymmetry was observed in the perception of the power structure: pharmacists were significantly more likely to indicate a unilateral model, initiated by them but dominated by the physician (21.8% vs. 5.2% of physicians) or dominated by them (13.4% vs. 2.6%). Physicians were significantly more likely to assess the relationship as a partnership (15.4% vs. 6.9% of pharmacists).
Conclusions: Occasional collaboration, as needed, as the dominant model of the physician-pharmacist relationship in the respondents' opinion, reduces extreme risks resulting from This lack of contact still does not provide a framework for an integrated system of patient protection against medication errors. Significant differences between representatives of both professions in the perception of relationships and persistent stereotypes can generate attribution errors and distrust. This blocks pharmacists' potential as independent experts in detecting, for example, drug interactions or polypharmacy. Ensuring maximum patient safety requires an urgent transition from incidental interactions to the systematic and structured implementation of documented pharmaceutical care, based on a partnership model of trust in the physician-pharmacist relationship.
Keywords: physician, pharmacist, interprofessional collaboration, COVID-19 pandemic, relationship models.
Anna Zagaja, Ph.D
Department of Humanities and Social Medicine, Medical University of Lublin, Lublin, Poland
Informed content - between formal requirement and quality
Świadoma zgoda pacjenta – między wymogiem formalnym a rzeczywistą jakością procesu informowania
Language / Język: English / angielski
Informed consent is one of the fundamental elements of modern medicine, combining legal obligations with the ethical considerations. In clinical practice, however, the process of obtaining consent is often reduced to fulfilling formal requirements, symbolized by the patient’s signature on the consent form. This approach raises the question of whether the formal correctness of the procedure truly guarantees the patient’s informed and autonomous choice.
The aim of this presentation is to analyze the tension between the formal and qualitative understandings of informed consent. From a legal perspective, the physician’s duty to inform and the proper documentation of consent are of key importance. In contrast, the ethical perspective emphasizes the patient’s understanding of the information provided, the voluntary nature of the decision, the opportunity to ask questions, and consideration of the patient’s values and preferences. The paper will discuss factors influencing the quality of the consent process, such as time constraints, patients’ health literacy, the complexity of medical information, and the asymmetry of the physician–patient relationship.
The presented analysis leads to the conclusion that the assessment of the quality of informed consent should go beyond formal criteria. Effective implementation of the patient’s right to self-determination requires treating consent not as a one-time act, but as a process of communication and joint therapeutic decision-making.
