Legal Supply Chain Research Articles

The legal and illegal supply chains of sea turtle eggs in Costa Rica

Many poor rural communities rely on biodiversity to fulfil basic livelihood requirements. Trade bans of natural resources often conflict with poverty alleviation and can stimulate illegal trade. Understanding markets, prices and profitability along both legal and illegal trade chains is crucial if appropriate regulatory mechanisms are to be implemented. Using the legal extraction of sea turtle eggs from Ostional, we used a mixed-methods approach to analyse the legal domestic supply chain. We used semi-structured interviews, questionnaires and data on the volume and destinations of egg sales to conduct a value chain analysis. We found an inequitable distribution of revenue along the legal supply chain, with middlemen profiting the most. Geographical barriers to trade flows and competition with illegal trade meant higher profits were achieved by sending the largest volume of the furthest distance. However, this increased the vulnerability of local traders to fluctuations in supply. Comparing legal and illegal trade routes, we identified potential laundering hotspots on the Caribbean coast of Costa Rica. Illegal eggs were cheaper than legal eggs available from Ostional. However, given the volume of Ostional eggs supplying the Caribbean and the fragility of local trader livelihoods, we advise caution in altering any management plan that could impact supply to this region, fearing a dwindling supply of legal eggs may stimulate illegal extraction in the Caribbean. Our research is directly relevant to the policies of the Convention on International Trade in Endangered Species, Convention on Biological Diversity and UN Sustainable Development Goals as our research enhances our understanding of how natural resource use can help alleviate poverty, improve local livelihoods and inform policy regarding wildlife laundering.

How can tracking and tracing systems give us a look at the dark side of the tobacco market?

The aim of this work is to present possible applications of the systems of tobacco traceability for guiding local enforcement against illicit trade. The proposed three-step strategy relies on a robust regression technique and Local Moran's I, a local indicator of spatial association, and aims at identifying retail outlets with significantly low sales compared to normal market conditions, which can indicate illegal sales activities. The ability of the method to produce alerts pointing to areas subject to illicit trade is tested on synthetic data in terms of precision and accuracy in different scenarios. Other metrics are also provided. Our approach performs well under different metrics and across various levels of illicit trade prevalence, achieving a precision of 94% under the main scenario and method parametrisation. The proposed strategy provides high-quality leads for investigations into geographical areas disproportionately susceptible to illicit trade, potentially unveiling any form of illegal sales, including those involving products that have never entered the legal supply chain. Therefore, it can be a valuable tool for law enforcement agencies to tackle illegal sales activities. The findings of this study support also the argument in favour of expanding tobacco traceability systems downstream to the full length of the supply chain.

IMPACT OF LEGAL FRAMEWORK AND SCM POLICIES ON SUPPLY CHAIN COLLABORATION: ROLE OF INFORMATION TECHNOLOGY

The purpose of this study is to investigate the Legal Framework and SCM policies governing supply chain collaboration, as well as the function of Information Technology as a mediator. The collection of direct data from respondents is a fundamental component of research methodology. Using a self-administered questionnaire from prior research and a Google form, the initial data was collected. data collected. Pakistani respondents from Sindh manufacturing firms. We have employed convenience sampling and cross-sectional methodology due to a variety of constraints, including time, location, and financial constraints. The effect of the legal framework on supply chain collaboration in manufacturing firms in Sindh, Pakistan. The findings demonstrated that direct effect have a significant and positive beta. The full mediation effect of information technology as a mediator between legal framework planning and supply chain collaboration in Sindh, Pakistan, manufacturing firms is demonstrated. In addition, the effect of SCM policies on supply chain collaboration in manufacturing firms in Sindh, Pakistan. The findings revealed that beta values for the direct effect are positive and significant. The full effect of information technology as a mediator between SCM policies and supply chain collaboration in manufacturing firms in Sindh, Pakistan, is demonstrated. The findings of this study highlight the importance of a supportive legal framework and efficient supply chain management policies to facilitate supply chain collaboration. In addition, it highlights the essential role that information technology plays in facilitating and enhancing supply chain partner collaboration.

The “V” model for decision analysis of additive manufacturing implementation

PurposeThis study aims to broaden the understanding of the additive manufacturing (AM) body of knowledge, presenting a model better suited to the current level of technological development that supports the decision to implement AM in industries, based on the experience of companies in the industry of orthopedic medical implants.Design/methodology/approachBased on the design-science research, the model for the decision to adopt the AM was designed and submitted to experts from the industry of orthopedic implants in Brazil for refinement. For the empirical test of the final model, interviews were used in a company that was considering implementing AM and in another that was not, to evaluate the model.FindingsThe model considers seven dimensions for decision analysis of AM implementation: legal constraints, financial, technological, operational, organizational, supply chain and external factors, being subdivided into 42 criteria that play a relevant role in the implementation decision. The analysis factor of each dimension and criteria are also presented.Originality/valueThe model seeks to be as complete as possible and can be used by various industrial productive sectors, incorporating the analysis of the requirements of health regulatory agencies, suitable for the analysis of the decision to implement AM for the manufacturing of medical implants, not found in other models.

Detection and Investigation of Counterfeit Medical Products in Slovenia*

This article provides insights into the detection, investigation and prosecution of counterfeit medical products in Slovenia and abroad. The article summarizes the reports of Interpol and the European Union’s activities in this area. It also uses the opinions and insights of experts in the field provided through interviews. While the scope of the problem surrounding counterfeit medical products has been increasing globally, the issue is not alarming in Slovenia. Counterfeit medical products (CFMP) were never found to enter the legal supply chain in Slovenia. In general, the incidence of counterfeit medical products in the scope of detection, investigation and prosecution is extremely low. The reasons for this may be in the ongoing debates about the definition of CFMPs and the continuing lack of public awareness about counterfeit medical products. If the public does not understand or even know about counterfeit medical products, they will fail to report potential encounters with them, thus making their detection even more difficult. The research study presented in this paper has (partly) confirmed that a sound and socially-oriented healthcare system in which the required medicines are widely available represents a deterrent against counterfeit medical products. Therefore, the legislative framework supporting such a system is most important.

Pharmacists' views on the impact of the Falsified Medicines Directive on community pharmacies: A cross-sectional survey

BackgroundThe Falsified Medicines Directive (FMD) was implemented to minimise the circulation of falsified medicines in the legal pharmaceutical supply chain. Whilst pharmacists are involved in the final step of the FMD requirements with the decommissioning of medicines at the point of supply to patients, limited research has been conducted to investigate the impact of fulfilling these requirements on the relevant stakeholders. ObjectiveTo examine community pharmacists' views on how the FMD has affected their practice. MethodsAn online survey was disseminated via email in June 2020 to pharmacists in Ireland (n = 4727), who were invited to participate if practising full time or part time in community pharmacies. Quantitative data were captured through multiple option and Likert-scale questions, and analysed using descriptive and inferential statistics. Qualitative data were captured by use of a free-text box, with the open comments analysed thematically. ResultsIn total, 618 valid responses were received (13.1% response rate). Most perceived that FMD requirements increased waiting times for patients (82%) and reduced time interacting with patients (65%). Only 28% agreed/strongly agreed that the introduction of the FMD legislation improves patient safety. In the open comments, the need for medicine authentication was acknowledged, but it was believed that this should be the wholesalers' responsibility, not pharmacists' responsibility. The additional step of medicines decommissioning was viewed as a time-consuming distraction to clinical checks that increased the risk for error. Pharmacists complained that they were not remunerated for the lost staff productivity or the additional software and equipment costs. Many pharmacists felt that the increased workload was disproportionate to the small risk of patients receiving falsified medicines. ConclusionsKey stakeholder engagement is required to optimise the implementation and integration of the FMD procedures into community pharmacy practice with minimal impact on dispensing and without compromising patient care.

Sounding out falsified medicines from genuine medicines using Broadband Acoustic Resonance Dissolution Spectroscopy (BARDS)

The trade in falsified medicine has increased significantly and it is estimated that global falsified sales have reached $100 billion in 2020. The EU Falsified Medicines Directive states that falsified medicines do not only reach patients through illegal routes but also via the legal supply chain. Falsified medicines can contain harmful ingredients. They can also contain too little or too much active ingredient or no active ingredient at all. BARDS (Broadband Acoustic Resonance Dissolution Spectroscopy) harnesses an acoustic phenomenon associated with the dissolution of a sample (tablet or powder). The resulting acoustic spectrum is unique and intrinsic to the sample and can be used as an identifier or signature profile. BARDS was evaluated in this study to determine whether a product is falsified or genuine in a rapid manner and at lower cost than many existing technologies. A range of genuine and falsified medicines, including falsified antimalarial tablets from south-east Asia, were tested, and compared to their counterpart genuine products. Significant differences between genuine and falsified doses were found in their acoustic signatures as they disintegrate and dissolve. Principal component analysis was employed to differentiate between the genuine and falsified medicines. This demonstrates that the tablets and capsules included here have intrinsic acoustic signatures which could be used to screen the quality of medicines.

Some issues for implementing the requirements for good practices (GxP). Good distribution practice (GDP)

Aim. To conduct a detailed study of the materials of good distribution practice.Materials and methods. The analysis of current guidance documents of good practices (GxP), namely Guideline 42-5.0:2014 “Medicines. Good Distribution Practice” has been performed. Interpretations for the implementation of good distribution practice requirements based on the experience of conducting audits of distribution companies for GDP compliance have been proposed.Results and discussion. It has been determined that Good Distribution Practice is a good practice that regulates the requirements for the subjects of the pharmaceutical market of Ukraine, who are engaged in the storage and distribution of medicinal products – wholesale distributors (in some cases, importers). Historical aspects of implementation of proper distribution practice have been studied. The problems of interpretation of the requirements of the guiding documents of Ukraine on good practices and time periods of improvement of its versions in the EU and Ukraine are presented. The principles and requirements of Guideline 42-5.0:2014 “Medicines. Good Distribution Practices” have been analyzed in detail, and directions for their implementation, benefits and risks associated with each item under research in the Guide are presented.Conclusions.The detailed analysis proposed allow minimizing the risks and errors that may have a negative impact on the quality of drugs. Introduction of a pharmaceutical quality system in the company in accordance with a requirements of good distribution practice will also prevent from entering of counterfeit medicines into the legal supply chain.

Spectroscopic techniques combined with chemometrics for fast on-site characterization of suspected illegal antimicrobials

The threats of substandard and falsified (SF) antimicrobials, posed to public health, include serious adverse drug effects, treatment failures and even development of antimicrobial resistance. Next to these issues, it has no doubt that efficient methods for on-site screening are required to avoid that SF antimicrobials reach the patient or even infiltrate the legal supply chain. This study aims to develop a fast on-site screening method for SF antimicrobials using spectroscopic techniques (mid infrared, benchtop near infrared, portable near infrared and Raman spectroscopy) combined with chemometrics. 58 real-life illegal antimicrobials (claiming 18 different antimicrobials and one beta-lactamase inhibitor) confiscated by the Belgian Federal Agency for Medicines and Health Products (FAMHP) and 14 genuine antimicrobials were analyzed and used to build and validate models.Two types of models were developed and validated using supervised chemometric tools. One was used for the identification of the active pharmaceutical ingredients (APIs) by applying partial least squares-discriminant analysis (PLS-DA) and another one was used for the detection of non-compliant (overdosed or underdosed) samples by applying PLS-DA, k-nearest neighbors (k-NN) and soft independent modelling by class analogy (SIMCA). The best model capable of identifying amoxicillin and clavulanic acid (co-amoxiclav), azithromycin, co-trimoxazole and amoxicillin was based on the mid-infrared spectra with a correct classification rate (ccr) of 100%. The optimal model capable of detecting non-compliant samples within the combined group of amoxicillin and co-amoxiclav via SIMCA showed a ccr for the test set of 88% (7/8) using mid infrared or benchtop near infrared spectroscopy. The best model for detecting non-compliant samples within the group of amoxicillin via SIMCA was obtained using mid-infrared or Raman spectra, resulting in a ccr of 80% for the test set (4/5) and a ccr for calibration of 100%. For the group of co-amoxiclav, the optimal models showed a ccr of 100% for the detection of non-compliant samples by applying mid-infrared, benchtop near infrared or portable near infrared spectroscopy. Taken together, the obtained models, hyphenating spectroscopic techniques and chemometrics, enable to easily identify suspected SF antimicrobials and to differentiate non-compliant samples from compliant ones.

PDG17 HOSPITAL COSTS ASSOCIATED WITH THE IMPLEMENTATION OF THE FALSIFIED MEDICINES DIRECTIVE IN HUNGARY

Medicine counterfeiting and its impact on patient safety is an emerging healthcare problem with an estimated annual prevalence of 0,005% (1,5 million packs) in the European legal drug supply chain. The aim of the Falsified Medicines Directive 2011/62/EU (FMD) is to prevent the entry of illegitimate medicines into the legal supply chain. There is, however, a relative lack of in-depth assessments of cost implications for hospital pharmacies. This study aims to evaluate the financial burden of FMD on Hungarian hospitals. Based on literature review and interviews with hospital pharmacy experts, a 37-question data collection form was developed to evaluate the implementation process before February 2019 and for the following stabilization period. Institutional data, infrastructural and IT developments and procedures related to authentication (verification and decommissioning) were evaluated in 3 large hospitals (900-1500 beds). Data collection started from February 2019. Authentication was performed upon shipment receipt. The average number of medication packs processed by the pharmacies was approximately 50 000 packs/month, of which on average 9 864 packs (ranging from 3 930 to 15 442) were FMD-compliant. That ratio is expected to increase over time. As human resource requirement, the added workload required 1 FTE pharmacy technician, with an estimated 7 719,23 € annual cost (ranging from 4138,77 € to 12 640,35 €). Initial one-off infrastructure and IT development costs were 2526,73 € (ranging from 77,99 € to 1 434,93 €). Our results illustrate that FMD may have a significant financial impact on hospital pharmacies. The findings of this study might offer a better understanding of influencing factors of FMD implementation in hospitals contributing to an optimized cost estimation methodology.

Implementing the EU Falsified Medicines Directive

The European Union's Falsified Medicines Directive, which came into force on 9 February, has laid down rigorous rules for pharmaceutical companies and pharmacists to follow in a bid to eradicate the pernicious impact of fake drugs infiltrating the legal supply chain. Joy Ogden reports on the progress so far.

Unique laser coding technology to fight falsified medicines

Based on WHO statistics, counterfeit medicines represent 10% of the global drug trade. According to Directive 2011/62/EU as regards the prevention of falsified medicines from entering into the legal supply chain, a unique identification should be put on each box of drugs to be able to track and trace them. The objective of this study is to develop a technology to mark an individual traceability code directly on the surface of the tablet. By using this technique, anyone with a camera-enabled phone and a suitable application installed should be able to authenticate these drugs. By marking the medicine's surface, patients could be protected from fake drugs.The aim of the present work was to study how different types of lasers affect the film coating of the tablet during the laser marking intervention.To sum up, the present findings may contribute to efficient and reliable laser marking solutions in the unique identification procedure. Based on our measurement results, it can be stated that the excimer UV laser is clearly the most suitable marking instrument for anti-counterfeiting coding on solid coated tablet form as this caused the least amount of chemical degradation of the polymer film.

A high crosslinking grade of hyaluronic acid found in a dermal filler causing adverse effects

Facial treatments with dermal fillers for medical or esthetic purposes occasionally give rise to adverse effects, ranging from temporary effects such as reddening of the skin, to long term effects such as hardening of tissue. There appears to be a relationship between the lifetime of the filler product and the risk for adverse effects. The lifetime of hyaluronic acid-based fillers is dependent on the presence and amount of crosslinking agents such as 1,4-butanediol diglycidyl ether (BDDE). It would therefore make sense to establish methodology to analyze the crosslinking grade of HA-based filler products on a routine basis. To this end, an analytical method was developed and validated to identify HA-BDDE-based fillers and to quantify their modification and crosslinking grade. The method was subsequently applied to products from the legal supply chain and the illegal market. It was found that the product Hyacorp H 1000, previously taken from the market, indeed contains a high modification grade and crosslinking grade, as was the assumed reason for the increased risk for adverse effects of this product. However, it was also shown that the Hyacorp products are highly unreliable in relation to their product composition in general. In this study, authentic products could not be distinguished from the illegal market products based on their modification and crosslinking grade.

Supply Chain Management based on Blockchain: A Systematic Mapping Study

Groundbreakingly, blockchain technology (BCT) has gained widespread acceptance and importance in the last few years. Implemented in different areas of applications such as social and legal industries, finance, smart property, and supply chain networks. This technology assures immutability and integrity of data without the need of a third trusted party. Furthermore, BCT could guarantee a transparent and decentralized transaction system in businesses and industries. Even though general research has been done in the BCT, however, there is a lack of systematic analysis on current research challenges regarding how BCT is effectively applicable in supply chain management (SCM). A systematic literature review (SLR) of SCM based on blockchain does not exist yet. This work aims to explore and analyse the state-ofthe-art on the BCT applications for SCM. We synthesize existing evidence, and identify gaps, available in the literature. The survey uses a systematic mapping study (SMS) method to examine 40 extracted primary studies from scientific databases.

Awareness of the implementation of the Falsified Medicines Directive among pharmaceutical companies' professionals in the European Economic Area.

Background:The Falsified Medicines Directive (FMD) is a response of the European Union to the increasing number of falsified medicines present in the legal supply chain within the Member States of the community. Effective implementation of the new regulations will depend on the effective cooperation of all parties involved in the distribution of medicinal products including the managers of pharmaceutical companies.Objective:The objective of the study was to examine awareness of the Implementation of the FMD among pharmaceutical company professionals in the European Economic Area.Methods:Sampling was conducted using a method called purposive sampling. An appropriate research tool in the form of an original questionnaire was made available to the respondents in electronic form. During the period from January 2016 to June 2016, 1,496 e-mail messages were sent. The response rate was 17.37%.Results:The study included 99 women (39.3%) and 153 men (60.7%). In the study group, 95.7% of people had heard of FMD. Doctors had rarely heard about the falsified medicine directive when compared to pharmacists (p=0.0063), people working in the pharmaceutical industry (p=0.0014), and respondents with a different professional profile (p=0.0114). In the study group, 89.6% of people were aware of the role of National Medicines Verification Organization in the process of implementing the provisions of FMD into the national system of distribution of medicinal products. The number of the respondents who knew the deadline for the implementation of FMD was significantly higher in the study population, i.e. 91.9% (p=0.0001). Both the younger respondents and those with lower level of education were less aware of the time requirements posed to national regulators (p=0.0003, p=0.0023, respectively).Conclusions:Awareness of the regulations related to the implementation of the FMD, although relatively high among pharmaceutical company professionals in the EEA, is still insufficient.

The role of German official medicines control laboratories in combating counterfeit medicines

An official medicines control laboratory (OMCL) provides an important contribution to combat counterfeit and illegal medicines. The OMCL supports the competent authorities in controlling the quality of authorised medicinal products in the legal supply chain. For detecting counterfeit medicines in the legal supply chain, arisk-based approach in choice of products is conducted. Furthermore, the OMCL analyses suspicious medicines from the illegal supply chain for any other authority. The chemical analysis of asuspicious sample is needed to identify such asample as acounterfeit medicine. The analytical results are fundamental for the evaluation of the legal status of the product and for the assessment of it's inherent hazard to public health. The global market of illegal medicines is rapidly changing. Therefore agood national and international working liaison and co-operation between laboratories and authorities is obligatory to protect public health. The OMCL provides important knowledge of new trends in counterfeit and illegal medicines. Hence, it is an essential part in surveillance of medicinal products. The efficient networking enables prompt official interventions. Thus, risks for the public health by substandard medicines were reduced. Beside the chemical analysis, the OMCL can help to raise public awareness about counterfeit and illegal medicines. In Germany, the risk of counterfeit medicines reaching patients through the legal supply chain is still low, but the possibility cannot be ignored.

Falsified medicines in parallel trade

The number of falsified medicines on the German market has distinctly increased over the past few years. In particular, stolen pharmaceutical products, aform of falsified medicines, have increasingly been introduced into the legal supply chain via parallel trading. The reasons why parallel trading serves as a gateway for falsified medicines are most likely the complex supply chains and routes of transport. It is hardly possible for national authorities to trace the history of amedicinal product that was bought and sold by several intermediaries in different EU member states. In addition, the heterogeneous outward appearance of imported and relabelled pharmaceutical products facilitates the introduction of illegal products onto the market. Official batch release at the Paul-Ehrlich-Institut offers the possibility of checking some aspects that might provide an indication of a falsified medicine. In some circumstances, this may allow the identification of falsified medicines before they come onto the German market. However, this control is only possible for biomedicinal products that have not received awaiver regarding official batch release. For improved control of parallel trade, better networking among the EU member states would be beneficial. European-wide regulations, e. g., for disclosure of the complete supply chain, would help to minimise the risks of parallel trading and hinder the marketing of falsified medicines.

Falsified Medicines Directive: Are We Heading in the Right Direction?

Falsified medicines for human use are an increasing problem in Europe. The Falsified Medicines Directive (FMD) 2011/62/EU provides measures to prevent the entry of falsified medicines into the legal supply chain by requiring the placing of safety features consisting of a unique identifier (Ul) and an anti-tampering device (ATD). Some concerns have arisen from patients regarding the effectiveness of UI and ATD in terms of safety. In contrast, the relevance of the supply source as a key point for patients and pharmacists, especially in hospitals, has not been sufficiently considered by the FMD. Endorsing more Good Procurement Practices and Good Distribution Practices may be more effective. The implementation of the FMD in hospitals is wasting human resources and increasing costs, which will likely result in a poor positive outcome. At both European and national levels, it is now urgent to mitigate the consequences of the FMD by updating the legislation.

The European Falsified Medicines Directive in Poland: background, implementation and potential recommendations for pharmacists

By February 2019, the Polish pharmaceutical industry, community and hospital pharmacies, wholesalers and parallel traders must all comply with the EU-wide Falsified Medicines Directive (FMD) legislation (2011/62/EU), to ensure that...

Establishing good authentication practice (GAP) in secondary care to protect against falsified medicines and improve patient safety

Sustained growth of falsified and counterfeit medicines in the legal supply chain is a critical threat to patients, (bio)pharmaceutical companies, caregivers, payers and pharmacists.1 ,2 The European Union (EU) Falsified...