Статті в журналах: "Medicine safety"

1

Bensoussan, Alan. "Herbal medicine safety." Medical Journal of Australia 183, no. 11-12 (November 25, 2005): 663. http://dx.doi.org/10.5694/j.1326-5377.2005.tb00031.x.

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2

Frassica, Frank J. "Safety in Medicine." Orthopedics 26, no. 11 (November 2003): 1100–1114. http://dx.doi.org/10.3928/0147-7447-20031101-05.

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3

Ruiqi Luo, Ruiqi Luo, and Luo Zhong Ruiqi Luo. "Medicine Safety Assessment Method based on Dynamic Dual Optimization." 網際網路技術學刊 23, no. 3 (May 2022): 611–19. http://dx.doi.org/10.53106/160792642022052303019.

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<p>As people pay more and more attention to medicine safety issues, related medicine safety monitoring platforms are also rapidly popularized. However, previous work has poor accuracy and low efficiency in medicine safety assessment. In this paper, the medicine safety evaluation index system of the medicine safety monitoring platform is determined from four aspects: medicine research and development, medicine market, medicine production, and medicine uses. In order to solve the problems of the medicine safety evaluation model, such as low evaluation accuracy, slow convergence speed, and long training time, the dynamic dual optimization of PSO-BP medicine safety assessment method (OPSO-BP) is proposed. The weights and thresholds of BP neural network are optimized by the PSO algorithm to improve the quality of assessment. In addition, we optimize PSO: use the cosine function to dynamically adjust the inertia weight w and use the average optimal position of the individual in the population to replace the optimal position of the individual. It improves the problem that the evaluation model in the traditional algorithm is easy to fall into the local optimal solution due to the lack of generalization ability. In this paper, the effectiveness of OPSO-BP is verified by comparative experiments with the designed questionnaire data of medicine safety evaluation.</p> <p> </p>

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4

Jain, Sachin Kumar. "Standardization & Safety Measures: Quality-Based Validation of Herbal Medicine." International Journal of Pharmacognosy & Chinese Medicine 3, no. 4 (2019): 1–3. http://dx.doi.org/10.23880/ipcm-16000182.

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Herbal medicines magnetize the curiosity of both patients and scientists, in all aspects of drug development from natural products and also for rationale of traditional medicine (TM). Numerous developing countries rely on TM because of their convenience and affordability, and scientists all over the world believe medicinal plants as a resource of new chemical entities and use them to isolate compounds such as Sennoside, quinine, strychnine, digoxin, morphine, taxol, atropine, and vinblastine

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5

Kadetz, Paul. "Safety Net—The Construction of Biomedical Safety in the Global ‘Traditional Medicine’ Discourse." Asian Medicine 10, no. 1-2 (October 3, 2015): 121–51. http://dx.doi.org/10.1163/15734218-12341348.

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This paper examines the social construction of the World Health Organization’s normative discourse of the safety of ‘traditional medicines’. The findings presented are based on archival research, a review of the literature, discourse analysis of who documents, semi-structured interviews with pertinent stakeholders, and participant experience at the Western Pacific Region Office of the who. This discourse of safety can be traced to the rise and global dominance of scientific medicine over plural health care and the construction of biomedical expertise. This paper argues that biomedicine’s global hegemony and construction of a dominant discourse of safety was, at least in part, influenced by the American Medical Association, The Flexner Report, The Rockefeller Foundation, the League of Nations Health Organization, the World Health Organization, and the who’s adoption of traditional Chinese medicine as a template for health care integration. This network of stakeholders influenced the construction and dissemination of the global biomedical discourse of safety and the purported ‘safe’ control, regulation, and integration of non-biomedical practices and practitioners via biomedical expertise.

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6

Saad, Bashar, Hassan Azaizeh, Ghassan Abu-Hijleh, and Omar Said. "Safety of Traditional Arab Herbal Medicine." Evidence-Based Complementary and Alternative Medicine 3, no. 4 (2006): 433–39. http://dx.doi.org/10.1093/ecam/nel058.

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Herbal remedies are widely used for the treatment and prevention of various diseases and often contain highly active pharmacological compounds. Many medicinal herbs and pharmaceutical drugs are therapeutic at one dose and toxic at another. Toxicity related to traditional medicines is becoming more widely recognized as these remedies become popular in the Mediterranean region as well as worldwide. Most reports concerning the toxic effects of herbal medicines are associated with hepatotoxicity although reports of other toxic effects including kidney, nervous system, blood, cardiovascular and dermatologic effects, mutagenicity and carcinogenicity have also been published in the medical literature. This article presents a systematic review on safety of traditional Arab medicine and the contribution of Arab scholars to toxicology. Use of modern cell biological, biochemical,in vitroandin vivotechniques for the evaluation of medicinal plants safety is also discussed.

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7

Jonas, Wayne B. "Safety in complementary medicine." Complementary Therapies in Medicine 4, no. 2 (April 1996): 141–42. http://dx.doi.org/10.1016/s0965-2299(96)80035-5.

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8

Dodd, Roger, W. Kurt Roth, Paul Ashford, Elizabeth M. Dax, and Girish Vyas. "Transfusion medicine and safety." Biologicals 37, no. 2 (April 2009): 62–70. http://dx.doi.org/10.1016/j.biologicals.2009.01.006.

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9

Li, Lu, Ping Chung Leung, Tony Kwok Hung Chung, and Chi Chiu Wang. "Systematic Review of Chinese Medicine for Miscarriage during Early Pregnancy." Evidence-Based Complementary and Alternative Medicine 2014 (2014): 1–16. http://dx.doi.org/10.1155/2014/753856.

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Background. Miscarriage is a very common complication during early pregnancy. So far, clinical therapies have limitation in preventing the early pregnancy loss. Chinese Medicine, regarded as gentle, effective, and safe, has become popular and common as a complementary and alternative treatment for miscarriages. However, the evidence to support its therapeutic efficacy and safety is still very limited.Objectives and Methods. To summarize the clinical application of Chinese Medicine for pregnancy and provide scientific evidence on the efficacy and safety of Chinese medicines for miscarriage, we located all the relevant pieces of literature on the clinical applications of Chinese Medicine for miscarriage and worked out this systematic review.Results. 339,792 pieces of literature were identified, but no placebo was included and only few studies were selected for systematic review and conducted for meta-analysis. A combination of Chinese medicines and Western medicines was more effective than Chinese medicines alone. No specific safety problem was reported, but potential adverse events by certain medicines were identified.Conclusions. Studies vary considerably in design, interventions, and outcome measures; therefore conclusive results remain elusive. Large scales of randomized controlled trials and more scientific evidences are still necessary to confirm the efficacy and safety of Chinese medicines during early pregnancy.

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10

Alotaibi, Majed H. "Medication Safety." Journal of Medical Science And clinical Research 11, no. 06 (June 30, 2023): 111–13. http://dx.doi.org/10.18535/jmscr/v11i6.21.

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Drug therapy is the most common healing mediation in medicine to recover patient well-being. In spite of the concentrating to help patients, there are numerous examples of inappropriate medication procedures and practices that compromise drug efficacy and lead to preventable medication errors, thereby jeopardizing patient health. Insecure medication practices leading to medication errors are one of the leading reasons of healthcare-related illness and mortality that globally published drug safety fact files. Understanding these characteristic risks will allow healthcare suppliers to better manage drawbacks and efforts to guarantee drug security in healthcare delivery. When safety policies and risk organization skills are integrated into health methods and medication rehearses, safer hospitals and main care can be achieved. Safety and danger management are integrated into healthcare arrangements and processes

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11

Chiba, Tsuyoshi, and Nanae Tanemura. "Differences in the Perception of Dietary Supplements between Dietary Supplement/Medicine Users and Non-Users." Nutrients 14, no. 19 (October 3, 2022): 4114. http://dx.doi.org/10.3390/nu14194114.

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Some patients use dietary supplements and medicines concomitantly, with an inappropriate perception of their safety and efficacy. To clarify the perception between dietary supplement and medicine users and non-users, we conducted an internet survey. In this survey, 38.9% of participants used dietary supplements, 32.6% used prescription medicines, and 14.7% used dietary supplements and prescription medicines concomitantly. Then, we conducted a further survey on four groups, dietary supplement and prescription medicine users, dietary supplement only users, prescription medicine only users, and non-users (500 each). Dietary supplement users had favorable outcomes in terms of both the safety and efficacy of dietary supplements compared to dietary supplement non-users. This perception of dietary supplements was independent from medicine use. The awareness of the Health Food Network consumer navigation site, which provides information about dietary supplements for consumers, was the highest among dietary supplement and prescription medicine users, but it was still low (2.2%). In conclusion, consumers who use dietary supplement and prescription medicine concomitantly have favorable outcomes for their safety and efficacy and a low awareness of their interaction. There is a need to provide information, especially regarding the risk of interaction, that takes into account the consumer’s situation.

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12

Sharwan, Gotmi, Parag Jain, Ravindra Pandey, and Shiv Shankar Shukla. "Toxicity profile of traditional herbal medicine." Journal of Ayurvedic and Herbal Medicine 1, no. 3 (December 25, 2015): 81–90. http://dx.doi.org/10.31254/jahm.2015.1306.

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Medicines obtained from natural sources have become the basis for pharmaceutical drugs. Traditional herbal medicines are naturally occurring plant derived substances; these have been used for treatment and cure of various diseases and as a nutraceuticals. Toxicological research and testing help to live safely and predict benefit from synthetic and natural substance while avoiding harm. The toxicity study is done for data profiling and safety of the herbal drugs, the toxicity study of various plant and herbal formulation are reported. This review briefly discusses the need of toxicity study, toxicity produced by plants and safe traditional herbal medicine.

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13

PEIXE, Roberta G., Maria C. SODRÉ, Beatriz B. OLIVEIRA, Luana P. GONÇALVES, Ian G. HALM, José C. CRUZ, Ana P. ANTUNES, and Rodrigo T. AMANCIO. "Active search about latex in injectable drugs for patient’s safety in medical therapy." Revista Brasileira de Farmácia Hospitalar e Serviços de Saúde 12, no. 4 (December 8, 2021): 703. http://dx.doi.org/10.30968/rbfhss.2021.124.0703.

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Objectives: To classify injectable drugs used in a general hospital inventory according to latex presence or absence in vials with rubber stoppers, antibiotics, and electrolytes bags. Methods: The information about latex content has been collected from medicine industries, after identification of authorized manufacturers in Brazil, through the National Health Surveillance Agency (ANVISA) medicine search database. Medicines have been grouped per pharmaceutical manufacturers, and data were collected through telephone or e-mail. Only written information from pharmaceutical companies were considered. Results: Among 161 medicines used in the hospital packaged in vials with rubber stoppers, antibiotics, and electrolytes bags, 123 (76.4%) medicine-related responses were received, covering 540 (82.2%) different presentations. For this, from 87 contacts, 70 (80.5%) companies responded and 65 (74.7%) provided information related to the presence or absence of the allergen. Among the medicine list, 8 (6.5%) were identified as containing latex (in 12 different presentations – 2.2%) and 101 medications (82.1%) in 507 presentations (93.9%) do not contain latex. The manufacturers responded that the medicine was latex-free, but could not confirm for raw materials (6 medicines – 4.9% - in 6 different presentations – 1.1%) and that they were unable to ensure there was no contact with latex during manipulation (4 medicines – 3.3% - in 8 different presentations – 1.5%). For 4 medicines (3.3%) in 7 different presentations (1.3%), the companies were inconclusive, as they could not confirm whether they were latex-free or not. Conclusion: Although latex is a known allergen, information about the presence of latex components in pharmaceutical packaging and package inserts needs improvement, since the active search identified 161 medicines packaged in vials with rubber stoppers, antibiotics, and electrolytes bags that failed to depict this information. The results of this survey endorse the Importance of displaying this information on medicines label or packaging in order to ensure healthcare professionals easy access and prompt consultation.

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14

Troisi, Roberta, and Carmine Garzillo. "A Model of European Medicine Agency (EMA)'s Decisions on Human Medicines." International Journal of Public and Private Healthcare Management and Economics 4, no. 1 (January 2015): 1–20. http://dx.doi.org/10.4018/ijpphme.2015010101.

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This paper is aimed at examining the European medicine agency decisions in the field of human medicines. Different classes of human medicines approved in the last five years have been classified. They have been analyzed considering: i) the relation between non generic drugs and generic drugs, ii) time of approval, iii) objectives of the clinical trials, iv) criteria of efficiency, efficacy, safety. By using the Summary of the European Public Assessment Report for every human medicine in the period 2010-2015, a dataset has been arranged. A Structural Equation Model analysis was carried out. The degree of efficiency, the degree of safety, the tradeoff between efficiency and safety that lead to the EMA approval decisions are conditioned by the nature of the medicines and the characteristics of their class. Different degrees of benefits and risks underpinning the decisions have been identified together with the consequent guiding principles that lead to the EMA decision process. A latent general “safety” factor at the basis of EMA decision process was assessed.

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15

Simões Teles, Ana Isabel. "Patient Safety in Transfusion Medicine." Journal Biomedical and Biopharmaceutical Research 11, no. 2 (December 2014): 173–78. http://dx.doi.org/10.19277/bbr.11.2.88.

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16

Cheng, King-Fai, and Ping-Chung Leung. "Safety in Chinese Medicine Research." Open Journal of Safety Science and Technology 02, no. 01 (2012): 32–39. http://dx.doi.org/10.4236/ojsst.2012.21005.

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17

Wolfram, Joy, Motao Zhu, Yong Yang, Jianliang Shen, Emanuela Gentile, Donatella Paolino, Massimo Fresta, et al. "Safety of Nanoparticles in Medicine." Current Drug Targets 16, no. 14 (November 19, 2015): 1671–81. http://dx.doi.org/10.2174/1389450115666140804124808.

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18

Miyakoshi, Koichi. "Patient Safety in Rehabilitation Medicine." Japanese Journal of Rehabilitation Medicine 58, no. 3 (March 18, 2021): 242–46. http://dx.doi.org/10.2490/jjrmc.58.242.

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19

Wagner, K. E. "Firearm Safety as Preventive Medicine." Journal of the American Board of Family Medicine 13, no. 1 (January 1, 2000): 86. http://dx.doi.org/10.3122/jabfm.13.1.86b.

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20

Lim, Kyoung-Soo. "Emergency medicine and social safety." Journal of the Korean Medical Association 54, no. 9 (2011): 904. http://dx.doi.org/10.5124/jkma.2011.54.9.904.

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21

Fishman, Scott M., Howard Smith, Alec Meleger, and Anthony J. Seibert. "Radiation safety in pain medicine." Regional Anesthesia and Pain Medicine 27, no. 3 (May 2002): 296–305. http://dx.doi.org/10.1097/00115550-200205000-00012.

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22

Williamson, Matthew. "Radiation Safety in Nuclear Medicine." Health Physics 84, no. 5 (May 2003): 667. http://dx.doi.org/10.1097/00004032-200305000-00019.

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23

O'Beirne, M., P. D. Sterling, K. Zwicker, P. Hebert, and P. G. Norton. "Safety incidents in family medicine." BMJ Quality & Safety 20, no. 12 (September 5, 2011): 1005–10. http://dx.doi.org/10.1136/bmjqs-2011-000105.

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24

Chi Wang, Lam. "Patient safety in emergency medicine." European Journal of Emergency Medicine 18, no. 5 (October 2011): 289. http://dx.doi.org/10.1097/mej.0b013e328348116c.

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25

Pease, William S., and Sarah L. Grove. "Electrical Safety in Electrodiagnostic Medicine." PM&R 5 (March 21, 2013): S8—S13. http://dx.doi.org/10.1016/j.pmrj.2013.03.019.

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FISHMAN, S., H. SMITH, A. MELEGER, and J. SEIBERT. "Radiation safety in pain medicine." Regional Anesthesia and Pain Medicine 27, no. 3 (May 2002): 296–305. http://dx.doi.org/10.1053/rapm.2002.32578.

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Bramlet, Roland. "Radiation Safety in Nuclear Medicine." Clinical Nuclear Medicine 24, no. 10 (October 1999): 826. http://dx.doi.org/10.1097/00003072-199910000-00029.

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28

Mills, Simon Y. "Safety awareness in complementary medicine." Complementary Therapies in Medicine 4, no. 1 (January 1996): 48–51. http://dx.doi.org/10.1016/s0965-2299(96)80056-2.

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29

Dinescu, Laurentiu Iulius, Darko Todorov, Michael Biglow, Yuliana Toderika, Henry Cohen, and Karishma Patel. "Medication Safety in Rehabilitation Medicine." Physical Medicine and Rehabilitation Clinics of North America 23, no. 2 (May 2012): 271–303. http://dx.doi.org/10.1016/j.pmr.2012.02.005.

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30

Duhaini, Ibrahim. "Radiation safety training in medicine." Physica Medica 32 (September 2016): 252. http://dx.doi.org/10.1016/j.ejmp.2016.07.538.

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31

Carr, Daniel F., and Munir Pirmohamed. "Precision medicine in drug safety." Current Opinion in Toxicology 23-24 (October 2020): 87–97. http://dx.doi.org/10.1016/j.cotox.2020.07.003.

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32

Ramlakhan, Shammi, Hasan Qayyum, Derek Burke, and Ruth Brown. "The safety of emergency medicine." Emergency Medicine Journal 33, no. 4 (November 3, 2015): 293–99. http://dx.doi.org/10.1136/emermed-2014-204564.

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33

Ward, Michael J. "Patient Safety in Emergency Medicine." Journal of Emergency Medicine 42, no. 4 (April 2012): 495. http://dx.doi.org/10.1016/j.jemermed.2011.10.001.

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34

Boullata, Joseph I., and Angela M. Nace. "Safety Issues with Herbal Medicine." Pharmacotherapy 20, no. 3 (March 2000): 257–69. http://dx.doi.org/10.1592/phco.20.4.257.34886.

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35

Kumar, K. "Safety nets in emergency medicine." European Journal of Emergency Medicine 5, no. 1 (March 1998): 138. http://dx.doi.org/10.1097/00063110-199803000-00106.

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36

BRAMLET, ROLAND. "Nuclear Medicine: Science and Safety." Clinical Nuclear Medicine 22, no. 1 (January 1997): 65. http://dx.doi.org/10.1097/00003072-199701000-00021.

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37

Katz, Harvey P., Dawn Kaltsounis, Liz Halloran, and Maureen Mondor. "Patient Safety and Telephone Medicine." Journal of General Internal Medicine 23, no. 5 (January 29, 2008): 517–22. http://dx.doi.org/10.1007/s11606-007-0491-y.

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38

Kessler, Chad S. "Patient Safety in Emergency Medicine." JAMA 301, no. 10 (March 11, 2009): 1070. http://dx.doi.org/10.1001/jama.2009.267.

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39

Fein, Alan M., and John E. Heffner. "Safety in Critical Care Medicine." Critical Care Clinics 21, no. 1 (January 2005): xiii—xiv. http://dx.doi.org/10.1016/j.ccc.2004.10.003.

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Camps, J. A. J. "Radiation safety in nuclear medicine." European Journal of Nuclear Medicine 28, no. 7 (July 2001): 948. http://dx.doi.org/10.1007/s002590100568.

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41

Jahromi, Behdad, Iulia Pirvulescu, Kenneth D. Candido, and Nebojsa Nick Knezevic. "Herbal Medicine for Pain Management: Efficacy and Drug Interactions." Pharmaceutics 13, no. 2 (February 11, 2021): 251. http://dx.doi.org/10.3390/pharmaceutics13020251.

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Complementary and alternative medicines such as herbal medicines are not currently part of the conventional medical system. As the popularity of and global market for herbal medicine grows among all age groups, with supporting scientific data and clinical trials, specific alternative treatments such as herbal medicine can be reclassified as a practice of conventional medicine. One of the most common conditions for which adults use herbal medicine is pain. However, herbal medicines carry safety concerns and may impact the efficacy of conventional therapies. Unfortunately, mechanisms of action are poorly understood, and their use is unregulated and often underreported to medical professionals. This review aims to compile common and available herbal medicines which can be used as an alternative to or in combination with conventional pain management approaches. Efficacy and safety are assessed through clinical studies on pain relief. Ensuing herb–drug interactions such as cytochrome modulation, additive and synergistic effects, and contraindications are discussed. While self-management has been recognized as part of the overall treatment strategy for patients suffering from chronic pain, it is important for practitioners to be able to also optimize and integrate herbal medicine and, if warranted, other complementary and alternative medicines into their care.

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A Adenuga, Babafunso, and Ayodeji O Adebayo. "Knowledge And Practice Of Healthcare Workers Regarding The Use Of Medicine Safety Surveillance Tools In A Primary Healthcare Setting." Recent Advances in Biology and Medicine 8, no. 4 (October 24, 2022): 1–6. http://dx.doi.org/10.18639/rabm.2022.980002.

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Despite the implementation of pharmacovigilance centers in developing countries and the institution of Therapeutic Committees at different healthcare delivery levels, the use of official medicine safety surveillance tools among healthcare workers is not widespread. In order to provide evidence on the knowledge and practice of healthcare professionals in the public sector on the use of medicine safety reporting tools, a cross-sectional survey using a self-administered questionnaire to assess the use of medicine safety surveillance tools amongst healthcare workers in Eenhana State Hospital was carried out. Data from the questionnaires were entered into the statistical package Epi Info® version 7 for analysis. About fifty percent of the healthcare workers in this study have identified at least one adverse drug reaction (ADR) in their professional practice. In contrast, only 29% reported ADR using at least one officially prescribed medicine safety reporting tool. The nursing cadre seems to have the least knowledge of medicine safety surveillance tools and pharmacovigilance practice. Pre-registration healthcare workers and continuing professional training for registered healthcare workers must be strengthened to encourage the use of medicines safety surveillance tools, in particular, and pharmacovigilance, in general.

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Wickramarathna, W. T. D., B. D. Kumara, A. G. S. U. Bandara, and L. C. P. T. Liyanaarachchie. "Cost saving and safety associated with centralised cytotoxic medicine reconstitution at National Hospital Kandy in 2019." Sri Lanka Journal of Health Research 2, no. 1 (December 31, 2022): 27–41. http://dx.doi.org/10.4038/sljhr.v2i1.50.

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Background: Cytotoxic medicines are associated with occupational risks to the operators. Therefore, centralised cytotoxic medicine reconstitution by trained pharmacists was initiated in Sri Lanka in 2009. Centralised parenteral medicine reconstitution has many advantages such as quality assurance, error reduction, wastage reduction and cost saving. However, none of these have been analyzed and reported in Sri Lankan settings before this study. If the cost saving is of a considerable value, Centralised Medicine Reconstitution (CMR) can be applied to other expensive medicines which will help to reduce the cost of medical supplies.Objectives: To analyse the cost saving and increased safety by reducing the medicine wastage due to the centralised parenteral cytotoxic medicine reconstitution in the National Hospital Kandy (NHK) in 2019.Methods: The study was conducted using the data recorded in 2019 on the daily medicine balance book maintained at the Cytotoxic Reconstitution Unit (CRU) in NHK. The number of vials used, the quantity of each dose, and the price of the parenteral cytotoxic medicine were used to calculate the total cost and the medicine wastage in the CRU and ward, and compared.Results: Theoretical medicine cost in wards to dispense 24 medicines was LKR 267.7 million, while the cost in the CRU was LKR 193.9 million. When it was reconstituted by the CRU, there was a wastage of 213,744.60 mg, and in wards, it was 4,353,153.60 mg. It showed a cost savings of LKR 73.8 million and a savings of 4,139,409 mg due to the CMR. The majority of cancer medications are cytotoxic, so reduction of medicine wastage also lowers the occupational risk and the risk to the environment.Conclusion: CMR of cytotoxic medicine in NHK has shown a 27% cost reduction and increased occupational and environmental safety as determined by 95% reduction in medicine wastage in 2019. CMR of other costly parenteral medicines in addition to the cytotoxics would help to reduce the cost on medicines.

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44

Yue, Liyuan, and Bing Liu. "Science Communication in the Debate about ‘Poison’ in Traditional Chinese Medicine." Cultures of Science 2, no. 2 (June 2019): 97–107. http://dx.doi.org/10.1177/209660831900200203.

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At the end of 2017, research revealed that herbal remedies containing aristolochic acid may cause liver cancer. This triggered a wide debate on ‘poison’ in traditional Chinese medicine. The popular TV show A Bite of China 3 also put the safety issue of traditional Chinese medicines as tonic food in the spotlight of public opinion. In fact, there are many misunderstandings about poison in descriptions of food safety and medicine safety on the internet and WeChat. From the perspective of science communication, our understanding of poison and its uses should transcend the monism of Western science.

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45

Bukatina, T. M., and E. V. Shubnikova. "Critical Overview of the Contents of Risk Management Plans for Medicines." Safety and Risk of Pharmacotherapy 10, no. 1 (January 31, 2022): 6–12. http://dx.doi.org/10.30895/2312-7821-2022-10-1-6-12.

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The pharmacovigilance system plays one of the key roles in ensuring safety and efficacy of medicine use. The risk management process helps to ensure the most favourable benefit/risk ratio of a medicine or combination of medicines both for the target populations and the general public. Unavailability of a risk management process for medicines may adversely affect the health of the general population. One of the major documents in medicine risk management is the risk management plan (RMP).The aim of the study was to analyse compliance of RMPs submitted as part of registration dossiers with the requirements of the Eurasian Economic Union (EAEU), and to analyse problems arising during their preparation.Materials and methods: the authors analysed 200 RMPs submitted from January 1 until August 31, 2021.Results: it was determined that the most frequent mistakes made by pharmacovigilance officers are related to medicine summaries in RMPs covering several medicines, medicine safety specification parts of RMPs, description of risks in the pharmacovigilance plan and description of risk minimisation measures, and insufficient representation of the key elements of the medicine efficacy and safety overview in the RMP summary. For instance, RMPs often lack information on the epidemiology of indications for target populations in the EAEU, or RMPs may lack some of the major risks reflected in the patient information leaflets, or lack assessment of safety risk minimisation actions, etc.Conclusions: proper preparation of RMPs that would comply with the EAEU Good Pharmacovigilance Practice is inconceivable without further professional training of pharmacovigilance officers.

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Kobuszewski, Bartosz. "Biological medicinal products: reference and biosimilar products – selected issues." Journal of Education, Health and Sport 11, no. 10 (October 14, 2021): 49–62. http://dx.doi.org/10.12775/jehs.2021.11.10.005.

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Biological therapies are being used in many chronic conditions. Development of biosimilar medicines gives chances for wider access to biological treatment. The aim of the review was to present legal regulations of the marketing authorisation of biological medicines in the context of biosimilars medicines. The article focuses on the legislation of the European Union, which was established on the beginning of the XXI century and is very complex and strict. In the first part of the article were described basic terms in this field, such as biological medicine, biosimilar medicine, reference medicine and generic medicie. It also shows differnces between biosimilar and generic medicines. Main difference concerns the manufacturing process, because of which biosimilar will never be identical to the reference medicine. Next part concentrates on the proces of registration of new biological medicines, especially in the area of medicines’ indications to use and controversies related to them. The last part presents issues of the safety monitoring of biological medicines on european level. The purpose of european law in that field is to guarantee every registred biologic therapy is safe for the patients.

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Mosihuzzaman, M., and M. Iqbal Choudhary. "Protocols on safety, efficacy, standardization, and documentation of herbal medicine (IUPAC Technical Report)." Pure and Applied Chemistry 80, no. 10 (January 1, 2008): 2195–230. http://dx.doi.org/10.1351/pac200880102195.

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This Technical Report compiles and analyzes the current scientific knowledge on herbal medicine and highlights the practical ways for ensuring the safety of herbal preparations and evaluating their claimed efficacy. Emphasis has been given to the methods for standardization of herbal medicine and the ways and means for moving forward to achieve the difficult goal of preparing herbal medicines of consistent quality and effects. Pragmatic approaches have been recommended to overcome the difficulties in (i) protecting intellectual property rights (IPR); (ii) producing safe, potent, standardized, and affordable herbal medicine; and (iii) documenting the knowledge base on herbal medicine in an easily accessible format.

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Taylor, Jeffrey Gordon, Stephen Ayosanmi, and Sujit S. Sansgiry. "Consumer Impressions of the Safety and Effectiveness of OTC Medicines." Pharmacy 11, no. 2 (March 10, 2023): 51. http://dx.doi.org/10.3390/pharmacy11020051.

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The public generally believes OTC medicines to be helpful for treating minor ailments. From a survey point of view, that position often originates from feedback obtained when these medicines are considered as one broad category. The objective of the study was to assess the properties of 15 categories of agents across three dimensions—effectiveness, safety, and familiarity. Data were gathered via an online non-random survey in one Canadian province, where residents were asked to consider 15 OTC medicine categories in terms of those dimensions. Five hundred and seventy-five completed surveys were obtained out of 3000 sent. On the 10-point effectiveness scale, values ranged from 5.1 (Athlete’s foot cream) to 7.3 (headache medicine). For safety, the medicines were closely grouped (6.0 to 7.4). Cough syrups for children were perceived as less safe than those for adults. There was a trend in that, as product familiarity grew, so did impressions of safety and effectiveness. The results support other reports where OTC medicines are described as safe and effective, although safety ratings were not particularly high. Responders considered these medicines to generally be higher in safety than effectiveness.

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Bowskill, Dianne. "Safety first on medicines." Nursing Standard 27, no. 13 (November 28, 2012): 70–71. http://dx.doi.org/10.7748/ns.27.13.70.s69.

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Gottschling, Sven, Oyedeji Ayonrinde, Arun Bhaskar, Marc Blockman, Oscar D’Agnone, Danial Schecter, Luis David Suárez Rodríguez, Sherry Yafai, and Claude Cyr. "Safety Considerations in Cannabinoid-Based Medicine." International Journal of General Medicine Volume 13 (December 2020): 1317–33. http://dx.doi.org/10.2147/ijgm.s275049.

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