Current pharmacological therapies for osteoarthritis are symptom-focused and aimed at controlling pain. However, currently approved symptom-modifying agents do not restore the structure and function of damaged joints. Symptomatic slow-acting drugs in osteoarthritis (SySADOAs), including the sulfated glycosaminoglycan, chondroitin sulfate, have shown promising beneficial effects on the pain and other symptoms of osteoarthritis, and some may also have a positive effect on cartilage, slowing the progression of joint deterioration in osteoarthritis. A highly-purified, standardized, pharmaceutical-grade preparation of chondroitin sulfate has shown activity in osteoarthritis and has become one of the most prescribed SySADOAs. However, in many countries, formulations of chondroitin sulfate of various sources and purity are available as food supplements or nutraceuticals. As the effects of chondroitin sulfate could vary according to the characteristics of the chondroitin sulfate employed, including source, purity, or structural organization, clinical data from well-designed studies of pharmaceutical-grade chondroitin sulfate should not be extrapolated to support clinical efficacy claims of food supplements; nor should results from trials of chondroitin sulfate-containing food supplements be used to draw conclusions about the efficacy of pharmaceutical-grade chondroitin sulfate. This article reviews the evidence for the role of highly-purified pharmaceutical-grade chondroitin sulfate in the treatment of osteoarthritis and examines the efficacy and safety concerns of other formulations of chondroitin sulfate. Highly-purified pharmaceutical-grade chondroitin sulfate has mild-to-moderate efficacy in the treatment of symptomatic osteoarthritis, with clinically meaningful efficacy.
{"title":"Access to Highly Purified Chondroitin Sulfate for Appropriate Treatment of Osteoarthritis: A Review","authors":"X. Chevalier, T. Conrozier","doi":"10.5301/maapoc.0000022","DOIUrl":"https://doi.org/10.5301/maapoc.0000022","url":null,"abstract":"Current pharmacological therapies for osteoarthritis are symptom-focused and aimed at controlling pain. However, currently approved symptom-modifying agents do not restore the structure and function of damaged joints. Symptomatic slow-acting drugs in osteoarthritis (SySADOAs), including the sulfated glycosaminoglycan, chondroitin sulfate, have shown promising beneficial effects on the pain and other symptoms of osteoarthritis, and some may also have a positive effect on cartilage, slowing the progression of joint deterioration in osteoarthritis. A highly-purified, standardized, pharmaceutical-grade preparation of chondroitin sulfate has shown activity in osteoarthritis and has become one of the most prescribed SySADOAs. However, in many countries, formulations of chondroitin sulfate of various sources and purity are available as food supplements or nutraceuticals. As the effects of chondroitin sulfate could vary according to the characteristics of the chondroitin sulfate employed, including source, purity, or structural organization, clinical data from well-designed studies of pharmaceutical-grade chondroitin sulfate should not be extrapolated to support clinical efficacy claims of food supplements; nor should results from trials of chondroitin sulfate-containing food supplements be used to draw conclusions about the efficacy of pharmaceutical-grade chondroitin sulfate. This article reviews the evidence for the role of highly-purified pharmaceutical-grade chondroitin sulfate in the treatment of osteoarthritis and examines the efficacy and safety concerns of other formulations of chondroitin sulfate. Highly-purified pharmaceutical-grade chondroitin sulfate has mild-to-moderate efficacy in the treatment of symptomatic osteoarthritis, with clinically meaningful efficacy.","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.5301/maapoc.0000022","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48004447","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The rise of digital technologies has created a complex online environment that now includes illicit Internet pharmacies, online facilitators, advertising sites, and foreign entities. Collectively, these networks create significant patient safety risks, including acting as unregulated access points encouraging prescription drug abuse. Although law enforcement is active in combating this form of cybercrime, there are several difficulties in prosecuting individuals involved in online prescription drug distribution. We characterize these challenges by conducting a comprehensive legal review and analysis of USA civil and criminal cases associated with online pharmacies. This is accomplished by reviewing legal documents/filings available via the Public Access to Court Electronic Records (PACER) database, the Drug Enforcement Agency's website, and structured search queries using the Google search engine. We found more than 100 cases, including criminal indictments, sentencing documents, judgments, forfeiture orders, motions, civil complaints, and restitution documents. Our review indicates that current legal tools and regulatory policies do not effectively deter this highly profitable criminal activity. Hence, we issue a “Call to Action,” advocating the need for more robust legal remedies and criminal penalties, and greater legal and policy coherence at the domestic, regional, and global level aimed at improving patient safety and ensuring the integrity of the drug supply chain.
{"title":"USA Criminal and Civil Prosecutions Associated with Illicit Online Pharmacies: Legal Analysis and Global Implications","authors":"C. Guerra, T. Mackey","doi":"10.5301/maapoc.0000020","DOIUrl":"https://doi.org/10.5301/maapoc.0000020","url":null,"abstract":"The rise of digital technologies has created a complex online environment that now includes illicit Internet pharmacies, online facilitators, advertising sites, and foreign entities. Collectively, these networks create significant patient safety risks, including acting as unregulated access points encouraging prescription drug abuse. Although law enforcement is active in combating this form of cybercrime, there are several difficulties in prosecuting individuals involved in online prescription drug distribution. We characterize these challenges by conducting a comprehensive legal review and analysis of USA civil and criminal cases associated with online pharmacies. This is accomplished by reviewing legal documents/filings available via the Public Access to Court Electronic Records (PACER) database, the Drug Enforcement Agency's website, and structured search queries using the Google search engine. We found more than 100 cases, including criminal indictments, sentencing documents, judgments, forfeiture orders, motions, civil complaints, and restitution documents. Our review indicates that current legal tools and regulatory policies do not effectively deter this highly profitable criminal activity. Hence, we issue a “Call to Action,” advocating the need for more robust legal remedies and criminal penalties, and greater legal and policy coherence at the domestic, regional, and global level aimed at improving patient safety and ensuring the integrity of the drug supply chain.","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.5301/maapoc.0000020","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44119020","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Expanded access programs raise complex ethical dilemmas regarding the use of experimental medicines to treat life-threatening medical conditions – issues for which there are no simple, monolithic solutions. Beyond the risks to an individual, how does society or a company balance the immediate needs of a critically ill individual versus the potential needs of many future patients? This article offers insights into and learning experiences from the case of a 7-year-old boy whose family sought access to an experimental antiviral medicine being developed by Chimerix, where the author was Chief Executive Officer. The high-profile #SaveJosh social media campaign helped to catalyze and crystalize the international debate on issues of ethics and equity in expanded access, raising questions regarding the role of patient advocacy and the impact of social media on healthcare and the biopharmaceutical industry. Additionally, the #SaveJosh campaign demonstrated how easily thoughtful dialogue can be overwhelmed by a hyper-immediacy that increases the intensity and scrutiny under which these issues must be addressed. Given that the decision to grant an expanded access request lies solely with the leadership of the company developing the experimental medicine, management must evaluate and balance a request against what is known about the safety and efficacy of the compound, where it is in its testing pathway, and any other complexities or risks identified during the development process. Furthermore, companies must craft and be prepared to explain their rationale, including the right not to make an experimental medicine available, to regulators, legislators, patient advocates, and patients in need.
{"title":"Ethical Crossroads: Expanded Access, Patient Advocacy, and the #SaveJosh Social Media Campaign","authors":"K. I. Moch","doi":"10.5301/MAAPOC.0000019","DOIUrl":"https://doi.org/10.5301/MAAPOC.0000019","url":null,"abstract":"Expanded access programs raise complex ethical dilemmas regarding the use of experimental medicines to treat life-threatening medical conditions – issues for which there are no simple, monolithic solutions. Beyond the risks to an individual, how does society or a company balance the immediate needs of a critically ill individual versus the potential needs of many future patients? This article offers insights into and learning experiences from the case of a 7-year-old boy whose family sought access to an experimental antiviral medicine being developed by Chimerix, where the author was Chief Executive Officer. The high-profile #SaveJosh social media campaign helped to catalyze and crystalize the international debate on issues of ethics and equity in expanded access, raising questions regarding the role of patient advocacy and the impact of social media on healthcare and the biopharmaceutical industry. Additionally, the #SaveJosh campaign demonstrated how easily thoughtful dialogue can be overwhelmed by a hyper-immediacy that increases the intensity and scrutiny under which these issues must be addressed. Given that the decision to grant an expanded access request lies solely with the leadership of the company developing the experimental medicine, management must evaluate and balance a request against what is known about the safety and efficacy of the compound, where it is in its testing pathway, and any other complexities or risks identified during the development process. Furthermore, companies must craft and be prepared to explain their rationale, including the right not to make an experimental medicine available, to regulators, legislators, patient advocates, and patients in need.","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.5301/MAAPOC.0000019","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48749684","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
J. Patel, E. Fox, M. Zocchi, Zone-En Lee, M. Mazer-Amirshahi
Introduction Drug shortages have become more severe in recent years; however, data describing how such shortages impact gastroenterology (GI) drugs are limited. We characterize longitudinal trends of drug shortages in the USA within the scope of GI practice. Methods Drug shortage data from the University of Utah Drug Information Service were analyzed from January 2001 to December 2014. A board certified gastroenterologist, an internal medicine physician, and a clinical pharmacist identified drug shortages within the scope of GI practice, whether they are used for high-acuity conditions, availability, formulation, or therapeutic category. Trends in the length of shortages for GI drugs were described using standard descriptive statistics and regression analysis. Results A total of 1,774 drug shortages were reported over the 14-year period. Of those, 253 shortages (14.3%) were classified within the scope of GI practice. The number of newly-reported GI drug shortages increased from 15 in 2001 to 44 in 2014. The majority of GI drugs (55.7%) were parenteral and 102 shortages (40.3%) were single source drugs. By the end of the study period, 44 (17.4%) GI drugs remained on active shortage with a median duration of 24.3 months (interquartile range [IQR] 6.9–32.1). The median duration for resolved shortages of GI drugs was 7.7 months (IQR 2.9–17.6). Conclusions There was a significant increase in shortages of drugs used in GI practice from 2001 to 2014. Many of these drugs were used for high-acuity conditions and alternative agents were also impacted. Gastroenterologists must be cognizant of current shortages in order to mitigate impact on patient care.
{"title":"Trends in United States Drug Shortages for Medications Used in Gastroenterology","authors":"J. Patel, E. Fox, M. Zocchi, Zone-En Lee, M. Mazer-Amirshahi","doi":"10.5301/maapoc.0000012","DOIUrl":"https://doi.org/10.5301/maapoc.0000012","url":null,"abstract":"Introduction Drug shortages have become more severe in recent years; however, data describing how such shortages impact gastroenterology (GI) drugs are limited. We characterize longitudinal trends of drug shortages in the USA within the scope of GI practice. Methods Drug shortage data from the University of Utah Drug Information Service were analyzed from January 2001 to December 2014. A board certified gastroenterologist, an internal medicine physician, and a clinical pharmacist identified drug shortages within the scope of GI practice, whether they are used for high-acuity conditions, availability, formulation, or therapeutic category. Trends in the length of shortages for GI drugs were described using standard descriptive statistics and regression analysis. Results A total of 1,774 drug shortages were reported over the 14-year period. Of those, 253 shortages (14.3%) were classified within the scope of GI practice. The number of newly-reported GI drug shortages increased from 15 in 2001 to 44 in 2014. The majority of GI drugs (55.7%) were parenteral and 102 shortages (40.3%) were single source drugs. By the end of the study period, 44 (17.4%) GI drugs remained on active shortage with a median duration of 24.3 months (interquartile range [IQR] 6.9–32.1). The median duration for resolved shortages of GI drugs was 7.7 months (IQR 2.9–17.6). Conclusions There was a significant increase in shortages of drugs used in GI practice from 2001 to 2014. Many of these drugs were used for high-acuity conditions and alternative agents were also impacted. Gastroenterologists must be cognizant of current shortages in order to mitigate impact on patient care.","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-12-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.5301/maapoc.0000012","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41732878","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
P. Minghetti, E. Lanati, J. Godfrey, O. Solà-Morales, O. Wong, Sonia Selletti
Introduction Almost 8,000 rare diseases exist worldwide, affecting approximately 350 million people. Nevertheless, only 5% receive a specific authorized or licensed treatment. The need for effective and rapidly available therapies is still unmet for many patients. Objective The objective is to define repurposing versus off-label drugs, and to evaluate pathways of repurposed drugs for rare non-oncological diseases in Italy, France, England, and Spain (the EU4 countries). Methods This original paper is based on 3 research activities: (i) a nonsystematic literature research; (ii) a questionnaire-based survey to regulatory experts; and (iii) research on approval timelines and therapy prices of repurposed non-oncology orphan drugs. Official approval dates in England are not available if the National Institute for Health and Care Excellence does not appraise the products. Results Only France provides a specific adaptive pathway from off-label to repurposed drugs. Pricing and reimbursement assessment for the drug samples varied across the EU4 countries: time-to-market for repurposed drugs versus new drugs is longer in all analyzed countries; that is, 979 days versus 462 days in Italy, 502 days versus 350 days in France, and 624 versus 378 days in Spain. Repurposed drugs have higher success rates from development to approval than novel drugs (30% vs. 11%). Small- and medium-sized enterprises owned 9 of 12 repurposed non-oncology orphan drugs, of which only 4 were reimbursed in all EU4 countries. Prices were more homogeneous across EU4 although the reimbursement rates were different. Conclusions Drug repurposing represents a great opportunity to treat rare non-oncological diseases. However, a more homogenous assessment across EU4 could ensure reimbursement and prices high enough to reward organizations investing in this field.
{"title":"From Off-Label to Repurposed Drug in Non-Oncological Rare Diseases: Definition and State of the Art in Selected EU Countries","authors":"P. Minghetti, E. Lanati, J. Godfrey, O. Solà-Morales, O. Wong, Sonia Selletti","doi":"10.5301/maapoc.0000016","DOIUrl":"https://doi.org/10.5301/maapoc.0000016","url":null,"abstract":"Introduction Almost 8,000 rare diseases exist worldwide, affecting approximately 350 million people. Nevertheless, only 5% receive a specific authorized or licensed treatment. The need for effective and rapidly available therapies is still unmet for many patients. Objective The objective is to define repurposing versus off-label drugs, and to evaluate pathways of repurposed drugs for rare non-oncological diseases in Italy, France, England, and Spain (the EU4 countries). Methods This original paper is based on 3 research activities: (i) a nonsystematic literature research; (ii) a questionnaire-based survey to regulatory experts; and (iii) research on approval timelines and therapy prices of repurposed non-oncology orphan drugs. Official approval dates in England are not available if the National Institute for Health and Care Excellence does not appraise the products. Results Only France provides a specific adaptive pathway from off-label to repurposed drugs. Pricing and reimbursement assessment for the drug samples varied across the EU4 countries: time-to-market for repurposed drugs versus new drugs is longer in all analyzed countries; that is, 979 days versus 462 days in Italy, 502 days versus 350 days in France, and 624 versus 378 days in Spain. Repurposed drugs have higher success rates from development to approval than novel drugs (30% vs. 11%). Small- and medium-sized enterprises owned 9 of 12 repurposed non-oncology orphan drugs, of which only 4 were reimbursed in all EU4 countries. Prices were more homogeneous across EU4 although the reimbursement rates were different. Conclusions Drug repurposing represents a great opportunity to treat rare non-oncological diseases. However, a more homogenous assessment across EU4 could ensure reimbursement and prices high enough to reward organizations investing in this field.","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.5301/maapoc.0000016","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49610747","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The European legislative framework is quickly moving towards transparency of the clinical trials data. The European Medicines Agency (EMA)'s Policy/0070, entered into force on January 1, 2015, marked a complete change of approach, moving from a reactive access, upon any interested parties' request, to a proactive publication of the clinical trials data. This approach will be further straightened with the entry into force of Regulation (EU) No. 536/2014 on clinical trials (CT Regulation), expected in 2019, following the activation of the European portal and database. The purpose of ensuring the transparency of the clinical trials data has to be balanced with compelling interests, including, in particular, the protection of the commercially confidential information (CCI) of the sponsors. The criteria to identify what data shall be considered as CCI and what specific reasons might be given by sponsors to support a request for keeping certain data confidential are not clearly stated by the applicable regulations. Moreover, European case law has not discussed this issue in the merits yet and, thus, no clarifications have been provided so far. This article intends to trace the development of the EMA's transparency policy, and make comparisons between the publication requirements under Policy/0070 and the CT Regulation, with particular regard to the issue of the protection of the sponsors' CCI.
{"title":"Publication of Clinical Trials Data: A New Approach to Transparency in the European Legislative Framework","authors":"E. Stefanini","doi":"10.5301/MAAPOC.0000018","DOIUrl":"https://doi.org/10.5301/MAAPOC.0000018","url":null,"abstract":"The European legislative framework is quickly moving towards transparency of the clinical trials data. The European Medicines Agency (EMA)'s Policy/0070, entered into force on January 1, 2015, marked a complete change of approach, moving from a reactive access, upon any interested parties' request, to a proactive publication of the clinical trials data. This approach will be further straightened with the entry into force of Regulation (EU) No. 536/2014 on clinical trials (CT Regulation), expected in 2019, following the activation of the European portal and database. The purpose of ensuring the transparency of the clinical trials data has to be balanced with compelling interests, including, in particular, the protection of the commercially confidential information (CCI) of the sponsors. The criteria to identify what data shall be considered as CCI and what specific reasons might be given by sponsors to support a request for keeping certain data confidential are not clearly stated by the applicable regulations. Moreover, European case law has not discussed this issue in the merits yet and, thus, no clarifications have been provided so far. This article intends to trace the development of the EMA's transparency policy, and make comparisons between the publication requirements under Policy/0070 and the CT Regulation, with particular regard to the issue of the protection of the sponsors' CCI.","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.5301/MAAPOC.0000018","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42347639","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction Head and neck cancer is a life-changing disease affecting all aspects in the life of a patient; eating, swallowing, talking, and socializing become very hard to deal with and comprehensive support is essential, regardless of the person's gender, age, social status, or background. The aim of this article is to describe the journey of a patient from a clinical and personal perspective, while discussing the importance of timely access to the most appropriate treatment based on outcome and on the patient's quality of life. Case presentation The journey of a head and neck cancer patient is illustrated from his own perspective. The clinical case also highlights a few key issues on medicine access. First, it has been a long time since any new treatment or drugs have been available to treat head and neck cancer patients, although the scenario might change drastically due to the introduction of immunotherapy. Second, it is unusual that even the most caring health care professional would consider a treatment that is not licensed in their country, even if it would have made a significantly positive difference to the patient's quality of life. Conclusions The increasing patient and health care professional's awareness of a solution to their problem with the use of unlicensed treatment, and the decreasing burden linked to identifying and sourcing unlicensed treatment, should help to optimize the management of these patients and significantly impact the outcome and their quality of life.
{"title":"Access to Optimal Treatment in Head and Neck Cancer: A Patient Perspective","authors":"C. Curtis","doi":"10.5301/MAAPOC.0000014","DOIUrl":"https://doi.org/10.5301/MAAPOC.0000014","url":null,"abstract":"Introduction Head and neck cancer is a life-changing disease affecting all aspects in the life of a patient; eating, swallowing, talking, and socializing become very hard to deal with and comprehensive support is essential, regardless of the person's gender, age, social status, or background. The aim of this article is to describe the journey of a patient from a clinical and personal perspective, while discussing the importance of timely access to the most appropriate treatment based on outcome and on the patient's quality of life. Case presentation The journey of a head and neck cancer patient is illustrated from his own perspective. The clinical case also highlights a few key issues on medicine access. First, it has been a long time since any new treatment or drugs have been available to treat head and neck cancer patients, although the scenario might change drastically due to the introduction of immunotherapy. Second, it is unusual that even the most caring health care professional would consider a treatment that is not licensed in their country, even if it would have made a significantly positive difference to the patient's quality of life. Conclusions The increasing patient and health care professional's awareness of a solution to their problem with the use of unlicensed treatment, and the decreasing burden linked to identifying and sourcing unlicensed treatment, should help to optimize the management of these patients and significantly impact the outcome and their quality of life.","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.5301/MAAPOC.0000014","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45097039","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Currently, counterfeit medicine is a significant issue for the pharmaceutical world, and it targets all types of therapeutic areas. The health consequences are appalling, since counterfeit medicines can contain impurities and the wrong chemical composition, and can be manufactured and/or stored in dreadful conditions. The provision of fast and reliable analytical tools can contribute to an efficient fight against this phenomenon. In this paper, an analytical strategy based on mobile and forensic laboratories is presented. The mobile equipment, composed of handheld x-ray fluorescence, Raman, infrared, and near-infrared spectrometers, and a handheld microscope, can be used as a first screening tool to detect counterfeits. The counterfeits can then be confirmed in a forensic-dedicated lab in which the chemical composition of the counterfeits is determined to evaluate the danger encountered by the patients. Relevant links with former counterfeit cases then can be revealed based on the analytical data, and can be interpreted from a forensic intelligence perspective in order to provide additional information for law enforcement.
{"title":"Innovative Strategy for Counterfeit Analysis","authors":"Klara Dégardin, Y. Roggo","doi":"10.5301/maapoc.0000013","DOIUrl":"https://doi.org/10.5301/maapoc.0000013","url":null,"abstract":"Currently, counterfeit medicine is a significant issue for the pharmaceutical world, and it targets all types of therapeutic areas. The health consequences are appalling, since counterfeit medicines can contain impurities and the wrong chemical composition, and can be manufactured and/or stored in dreadful conditions. The provision of fast and reliable analytical tools can contribute to an efficient fight against this phenomenon. In this paper, an analytical strategy based on mobile and forensic laboratories is presented. The mobile equipment, composed of handheld x-ray fluorescence, Raman, infrared, and near-infrared spectrometers, and a handheld microscope, can be used as a first screening tool to detect counterfeits. The counterfeits can then be confirmed in a forensic-dedicated lab in which the chemical composition of the counterfeits is determined to evaluate the danger encountered by the patients. Relevant links with former counterfeit cases then can be revealed based on the analytical data, and can be interpreted from a forensic intelligence perspective in order to provide additional information for law enforcement.","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.5301/maapoc.0000013","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44709740","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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.
{"title":"Falsified Medicines Directive: Are We Heading in the Right Direction?","authors":"R. Frontini","doi":"10.5301/maapoc.0000011","DOIUrl":"https://doi.org/10.5301/maapoc.0000011","url":null,"abstract":"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.","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.5301/maapoc.0000011","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47721057","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Maarten Van Baelen, P. Dylst, C. Pereira, J. Verhaeghe, Koen Nauwelaerts, Susie Lyddon
The implementation of the Falsified Medicines Directive, and its Delegated Regulation with detailed specifications of safety features, will provide an additional obstacle for counterfeiters. The implementation of the Directive aims to prevent falsified medicines from reaching patients, and is in the interest of public health. However, the financial burden for manufacturers to implement these additional safety features, as well as the repository system that will allow the verification of authenticity of individual packs of medicine, may threaten the availability of medicines.
{"title":"Fighting Counterfeit Medicines in Europe: The Effect on Access to Medicines","authors":"Maarten Van Baelen, P. Dylst, C. Pereira, J. Verhaeghe, Koen Nauwelaerts, Susie Lyddon","doi":"10.5301/maapoc.0000010","DOIUrl":"https://doi.org/10.5301/maapoc.0000010","url":null,"abstract":"The implementation of the Falsified Medicines Directive, and its Delegated Regulation with detailed specifications of safety features, will provide an additional obstacle for counterfeiters. The implementation of the Directive aims to prevent falsified medicines from reaching patients, and is in the interest of public health. However, the financial burden for manufacturers to implement these additional safety features, as well as the repository system that will allow the verification of authenticity of individual packs of medicine, may threaten the availability of medicines.","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.5301/maapoc.0000010","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46067060","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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