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Societal Side Effects: The Wider Impact of Pharmaceuticals on Society

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A special issue of International Journal of Environmental Research and Public Health (ISSN 1660-4601).

Deadline for manuscript submissions: closed (31 December 2019) | Viewed by 94856

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Special Issue Editors

Prof. Dr. Claus Jacob

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Division of Bioorganic Chemistry, School of Pharmacy, Saarland University, D-66123 Saarbruecken, Germany
Interests: bioorganic chemistry; catalytic sensor/effector agents; epistemology; intracellular diagnostics; nanotechnology; natural products; reactive sulfur and selenium species; redox regulation via the cellular thiolstat
Special Issues, Collections and Topics in MDPI journals

Prof. Dr. Barbara Osimani

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Department of Biomedical Sciences and Public Health, Medical Faculty, Polytechnic University of the Marche, via Tronto 10/a, 60126 Ancona, Italy
Interests: (formal) epistemology; foundations of statistics; causal inference; philosophical theories of causality; evidence (amalgamation); medical methodology; philosophy of medicine; philosophy of pharmacology; philosophy of risk; the precautionary principle

Prof. Dr. Klaus Ruthenberg

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Guest Editor

Faculty of Science and Academic Centre for Sciences and Humanities, Coburg University for Applied Sciences and Arts, D-96450 Coburg, Germany
Interests: History and Philosophy of Chemistry; Philosophizing chemists; chemical concepts; substance; analytical and synthetical aspects; ethics of chemistry; potentiality and temporality

Special Issue Information

Dear Colleagues,

Pharmaceuticals are of the utmost importance in modern medicine where they represent the central topic of pharmacy research, development and applications. Natural or synthetic remedies are generally associated with considerable benefits to human and animal health, limited only by the occurrence of so-called “side effects”, and otherwise appear to be largely unproblematic. Nonetheless, the administration of medications to patients and the investigation of their specific pharmaceutical outcomes represent only one aspect of the interaction between pharmacy and society. At closer inspection, a wider impact on society and the environment emerges, clearly surpassing the traditional domain of discussions attributed to pharmacy. To fathom these meta-pharmaceutical issues, one has to contemplate and confront them from a wider angle, employing sociological and philosophical methodologies.

This Special Issue will therefore consider some of the recent developments in the field of pharmacy and society, often fuelled by, but not limited to, public scandals. Prominent examples of such “societal side effects” may include the presence, or lack of, “active ingredients” in pharmaceuticals, including undesired contaminations on the one hand and placebos sold for profit on the other, or the value and adequate processing of expired medicines. Whilst such topics originate within the discipline of pharmacy, they also raise serious ethical, ecological, economical and political concerns, and represent just some of the more obvious and prominent examples of an increasingly rich interface of joint pharmaceutical and soci(et)al research.

We hope that such a multidisciplinary discourse on pharmaceutical topics from different meta-perspectives will stimulate a broader professional debate on issues affecting both pharmacy and society, and eventually also strengthen this pivotal disciplinary interface in research and teaching. Whilst the main focus will be on the analysis of epistemic and moral values of serious, still often overlooked “side effects”, the dialogue also welcomes less prominent examples.

We anticipate that such an unconventional multidisciplinary approach crossing the traditional borders between the natural and social sciences may open up new avenues of thought, and interactions with less obvious disciplines which in the future may provide considerable impetus in and to this field.

Prof. Dr. Claus Jacob
Prof. Dr. Barbara Osimani
Prof. Dr. Klaus Ruthenberg
Guest Editors

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Keywords

Epistemology
Ethics
Meta-Perspective
Pharmaceuticals
Pharmacy
Society

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Published Papers (8 papers)

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Research

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13 pages, 1801 KiB

Open AccessArticle

Chemical Impurities: An Epistemological Riddle with Serious Side Effects

by Ahmad Yaman Abdin, Prince Yeboah and Claus Jacob

Int. J. Environ. Res. Public Health 2020, 17(3), 1030; https://doi.org/10.3390/ijerph17031030 - 6 Feb 2020

Cited by 14 | Viewed by 6644

Abstract

Chemical synthesis is a science and an art. Rooted in laboratory or large-scale manufacture, it results in certain side products, eventually compromising the integrity of the final products. Such “impurities” occur in small amounts and, within chemistry itself, are of little concern. In pharmacy, in contrast, impurities increase the potential for toxicity, side effects, and serious implications for human health and the environment. The pharmaceutical regulatory agencies have therefore developed regulatory and strategic systems to minimize the chemical presence or biological impact of such substances. Here, pharmaceuticals are turned from impure into more defined materials as part of a complex socio-technological system revolving around and constantly evolving its specific rules and regulations. Whilst modern analytical methods indicate the presence of impurities, the interpretations of corresponding results are gated by risk management and agreed thresholds. Ironically, this allows for entities with no identified chemical structures, and hence epistemologically outside chemistry, to be regulated in pharmaceutical products. We will refer to such substances which are not, epistemologically speaking, “chemicals” as Xpurities, in order to distinguish them from recognized and identified impurities. The presence of such Xpurities is surprisingly common and constitutes a major issue in pharmaceutical research and practice. We propose a Space of Information to deal with such impurities based on values regarding the presence, chemical identities, and biological activities. It is anticipated that this may enable pharmacists to handle such Xpurities more efficiently. Full article

(This article belongs to the Special Issue Societal Side Effects: The Wider Impact of Pharmaceuticals on Society)

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19 pages, 424 KiB

Open AccessArticle

New Insights in Computational Methods for Pharmacovigilance: E-Synthesis, a Bayesian Framework for Causal Assessment

by Francesco De Pretis and Barbara Osimani

Int. J. Environ. Res. Public Health 2019, 16(12), 2221; https://doi.org/10.3390/ijerph16122221 - 24 Jun 2019

Cited by 9 | Viewed by 4962

Abstract

Today’s surge of big data coming from multiple sources is raising the stakes that pharmacovigilance has to win, making evidence synthesis a more and more robust approach in the field. In this scenario, many scholars believe that new computational methods derived from data mining will effectively enhance the detection of early warning signals for adverse drug reactions, solving the gauntlets that post-marketing surveillance requires. This article highlights the need for a philosophical approach in order to fully realize a pharmacovigilance 2.0 revolution. A state of the art on evidence synthesis is presented, followed by the illustration of E-Synthesis, a Bayesian framework for causal assessment. Computational results regarding dose-response evidence are shown at the end of this article. Full article

(This article belongs to the Special Issue Societal Side Effects: The Wider Impact of Pharmaceuticals on Society)

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10 pages, 589 KiB

Open AccessArticle

Influence of Risk of Drug–Drug Interactions and Time Availability on Patient Trust, Satisfaction, and Cooperation with Clinical Pharmacists

by Ying-Chyi Chou, Van Thac Dang, Hsin-Yi Yen and Kuan-Ming Lai

Int. J. Environ. Res. Public Health 2019, 16(9), 1566; https://doi.org/10.3390/ijerph16091566 - 5 May 2019

Cited by 6 | Viewed by 3290

Abstract

Patients with multiple diseases requiring several medications often face the risk of drug–drug interactions (DDIs). Such patients need more care and services from clinical pharmacists. Given the importance of this issue in clinical medicine, the present study aims to investigate how DDIs and time availability affect patient trust in clinical pharmacists and how patient trust influences patient satisfaction and cooperation between patients and clinical pharmacists. Sample data of 741 patients in central Taiwan hospitals were analyzed, and the results of structural equation modeling showed that DDIs and time availability positively affect patient trust, which, in turn, positively influenced patient satisfaction and cooperation between patients and clinical pharmacists. Overall, the results indicated that patient satisfaction is an important predictor of cooperation between patients and clinical pharmacists. Full article

(This article belongs to the Special Issue Societal Side Effects: The Wider Impact of Pharmaceuticals on Society)

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15 pages, 2041 KiB

Open AccessArticle

Improving Patient Access to New Drugs in South Korea: Evaluation of the National Drug Formulary System

by Seung-Lai Yoo, Dae-Jung Kim, Seung-Mi Lee, Won-Gu Kang, Sang-Yoon Kim, Jong Hyuk Lee and Dong-Churl Suh

Int. J. Environ. Res. Public Health 2019, 16(2), 288; https://doi.org/10.3390/ijerph16020288 - 21 Jan 2019

Cited by 30 | Viewed by 15082

Abstract

This study reviews and evaluates the national drug formulary system used to improve patient access to new drugs by making reimbursement decisions for new drugs as part of the South Korean national health insurance system. The national health insurance utilizes three methods for improving patient access to costly drugs: risk-sharing agreements, designation of essential drugs, and a waiver of cost-effectiveness analysis. Patients want reimbursement for new drugs to be processed quickly to improve their access to these drugs, whereas payers are careful about listing them given the associated financial burden and the uncertainty in cost-effectiveness. However, pharmaceutical companies are advocating for drug prices above certain thresholds to maintain global pricing strategies, cover the costs of drug development, and fund future investments into research and development. The South Korean government is expected to develop policies that will improve patient access to drugs with unmet needs for broadening health insurance coverage. Simultaneously, the designing of post-listing management methods is warranted for effectively managing the financial resources of the national health insurance system. Full article

(This article belongs to the Special Issue Societal Side Effects: The Wider Impact of Pharmaceuticals on Society)

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20 pages, 4421 KiB

Open AccessArticle

An Inventory Model for Deteriorating Drugs with Stochastic Lead Time

by Jian Li, Lu Liu, Hao Hu, Qiuhong Zhao and Libin Guo

Int. J. Environ. Res. Public Health 2018, 15(12), 2772; https://doi.org/10.3390/ijerph15122772 - 7 Dec 2018

Cited by 12 | Viewed by 4526

Abstract

Inventory management of deteriorating drugs has attracted considerable attention recently in hospitals. Drugs are a kind of special product. Two characteristics of some drugs are the shorter shelf life and high service level. This causes hospitals a great deal of difficulty in inventory management of perishable drugs. On one hand, hospitals should increase the drug inventory to achieve a higher service level. On the other hand, hospitals should decrease the drug inventory because of the short shelf life of drugs. An effective management of pharmaceuticals is required to ensure 100% product availability at the right time, at the right cost, in good conditions to the right customers. This requires a trade-off between shelf-life and service level. In addition, many uncontrollable factors can lead to random lead time of drugs. This paper focuses on deteriorating drugs with stochastic lead time. We have established a stochastic lead time inventory model for deteriorating drugs with fixed demand. The lead time obeyed a certain distribution function and shortages were allowed. This model also considered constraints on service level, stock space and drug shelf life. Through the analysis of the model, the shelf life of drugs and service level were weighted in different lead time distributions. Empirical analysis and sensitivity analysis were given to get reach important conclusions and enlightenment. Full article

(This article belongs to the Special Issue Societal Side Effects: The Wider Impact of Pharmaceuticals on Society)

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Review

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17 pages, 2833 KiB

Open AccessReview

Expired Medication: Societal, Regulatory and Ethical Aspects of a Wasted Opportunity

by Faez Alnahas, Prince Yeboah, Louise Fliedel, Ahmad Yaman Abdin and Khair Alhareth

Int. J. Environ. Res. Public Health 2020, 17(3), 787; https://doi.org/10.3390/ijerph17030787 - 27 Jan 2020

Cited by 69 | Viewed by 21425

Abstract

A massive volume of expired medications amasses annually around the world because of pharmaceutical overprescription, combined with overproduction. The accumulation of pharmaceutical waste imposes ecological, economic and social/ethical burdens. Managing this presumed “waste” has developed into a global challenge due to the absence of specific regulations, unreasonable behavior of the patients, and an improper understanding of the concept of “expired medications” in general. This paper summaries, first, the recent literature reporting practices related to the disposal of unused medications. In this context, 48 papers from 34 countries with a total of 33,832 participants point towards a significant lack of public awareness regarding the appropriate disposal of such biologically potent chemicals. These findings are corroborated by a local survey on the disposal practices of unused medicines among pharmacy students at Saarland University. The regulatory aspects surrounding this topic, often based on the official guidelines for the disposal of expired medications and local waste management strategies, are then discussed in light of these findings. Finally, a closer inspection of the epistemic values of expired medications and different strategies for managing expired medications have been reviewed. Full article

(This article belongs to the Special Issue Societal Side Effects: The Wider Impact of Pharmaceuticals on Society)

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16 pages, 1032 KiB

Open AccessReview

The Community Pharmacist: Perceived Barriers and Patient-Centered Care Communication

by Maria Laura Ilardo and Antonio Speciale

Int. J. Environ. Res. Public Health 2020, 17(2), 536; https://doi.org/10.3390/ijerph17020536 - 15 Jan 2020

Cited by 108 | Viewed by 33267

Abstract

Nowadays, the classic perception of the pharmaceutical profession in community pharmacies is facing worldwide extinction due to many factors. Among the numerous factors, online pharmacies are increasingly gaining ground thanks to their ability to facilitate customer demand. Nevertheless, they are endangering “face-to-face” contact, affecting the building of customer loyalty based on direct “human” interaction, and consequently reducing pharmacists to mere commercial figures. Patient-centered care communication is emphasized as the essential element to build a solid and appropriate interpersonal relationship with the patient, to make the consultancy process effective, and to strengthen the pharmacist’s professionalism in community pharmacy. This paper presents a narrative review of existing literature with the first aim of pinpointing the factors affecting pharmacy professional practice, and secondly, of how to improve patient-centered communication skills. A more widespread introduction of in-depth study and practice of behavioral, communication, educational, and sociological methodologies and techniques would allow for the development of more effective skills used for providing an efficient consultancy service, improving the capacity of future professionals to approach public relations. Full article

(This article belongs to the Special Issue Societal Side Effects: The Wider Impact of Pharmaceuticals on Society)

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Other

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14 pages, 3981 KiB

Open AccessPerspective

Disambiguating “Mechanisms” in Pharmacy: Lessons from Mechanist Philosophy of Science

by Ahmad Yaman Abdin, Claus Jacob and Lena Kästner

Int. J. Environ. Res. Public Health 2020, 17(6), 1833; https://doi.org/10.3390/ijerph17061833 - 12 Mar 2020

Cited by 4 | Viewed by 3717

Abstract

Talk of mechanisms is ubiquitous in the natural sciences. Interdisciplinary fields such as biochemistry and pharmacy frequently discuss mechanisms with the assistance of diagrams. Such diagrams usually depict entities as structures or boxes and activities or interactions as arrows. While some of these arrows may indicate causal or componential relations, others may represent temporal or operational orders. Importantly, what kind of relation an arrow represents may not only vary with context but also be underdetermined by empirical data. In this manuscript, we investigate how an analysis of pharmacological mechanisms in terms of producing and underlying mechanisms—as discussed in the contemporary philosophy of science—may shed light on these issues. Specifically, we shall argue that while pharmacokinetic mechanisms usually describe causal chains of production, pharmacodynamics tends to focus on mechanisms of action underlying the in vivo effects of a drug. Considering the action of thyroid gland hormones in the human body as a case study, we further demonstrate that pharmacodynamic schemes tend to incorporate entities and interactions on multiple levels. Yet, traditional pharmacodynamic schemes are sketched “flat”, i.e., non-hierarchically. We suggest that transforming flat pharmacodynamic schemes into mechanistic multi-level representations may assist in disentangling the different kinds of mechanisms and relations depicted by arrows in flat schemes. The resulting Baumkuchen model provides a powerful and practical alternative to traditional flat schemes, as it explicates the relevant mechanisms and relations more clearly. On a more general note, our discussion demonstrates how pharmacology and related disciplines may benefit from applying concepts from the new mechanist philosophy to guide the interpretation of scientific diagrams. Full article

(This article belongs to the Special Issue Societal Side Effects: The Wider Impact of Pharmaceuticals on Society)

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