Critical Success Factors and Traceability Technologies for Establishing a Safe Pharmaceutical Supply Chain

Drug counterfeits have been an international issue for almost two decades, and the latest statistics show that fake medications will continue to penetrate legitimate pharmaceutical supply chains (PSCs). Therefore, identifying the issues faced by PSCs is essential to combat the counterfeit drug problem, which will require the implementation of technologies in various phases of the PSC to gain better visibility. In this regard, a literature review was conducted to fulfill the following objectives: (i) review the application of traceability technologies in various PSC phases to detect counterfeits; (ii) analyze the various barriers affecting the establishment of a safe PSC and the critical success factors used to overcome those barriers; and (iii) develop a conceptual framework and guidelines to demonstrate the influence of traceability technologies and success factors on overcoming the various barriers in different phases of the PSC. The major finding of this review was that traceability technologies and the critical success factors have a significant influence on overcoming the barriers to establishing a safe PSC.

Proof-of-Concept of Detection of Counterfeit Medicine through Polymeric Materials Analysis of Plastics Packaging

The detection of counterfeit pharmaceuticals is always a major challenge, but the early detection of counterfeit medicine in a country will reduce the fatal risk among consumers. Technically, fast laboratory testing is vital to develop an effective surveillance and monitoring system of counterfeit medicines. This study proposed the combination of Attenuated Total Reflectance Fourier Transform Infrared (ATR-FTIR) and Differential Scanning Calorimetry (DSC) for the quick detection of counterfeit medicines, through the polymer analysis of blister packaging materials. A sample set containing three sets of original and counterfeit medicine was analyzed using ATR-FTIR and DSC, while the spectra from ATR-FTIR were employed as a fingerprint for the polymer characterization. Intending to analyze the polymeric material of each sample, DSC was set at a heating rate of 10 °C min−l and within a temperature range of 0- 400 °C, with nitrogen as a purge gas at a flow rate of 20 ml min−an. The ATR-FTIR spectra revealed the chemical characteristics of the plastic packaging of fake and original medicines. Further analysis of the counterfeit medicine’s packaging with DSC exhibited a distinct difference from the original due to the composition of polymers in the packaging material used. Overall, this study confirmed that the rapid analysis of polymeric materials through ATR-FTIR and comparing DSC thermograms of the plastic in their packaging effectively distinguished counterfeit drug products.

Counterfeit formulations: analytical perspective on anorectics

Purpose This paper examines the scope of anorectics in counterfeit weight-reducing formulations and provides insight into the present state of research in determining such adulterants. Analytical techniques utilised in profiling adulterants found in slimming products, including limitations and mitigation steps of these conventional methods are also discussed. The current legal status of the anorectics and analogues routinely encountered in non-prescription slimming formulations is also explored. Methods All reviewed literature was extracted from Scopus, Web of Science, PubMed, and Google Scholar databases using relevant search terms, such as, ‘counterfeit drugs’, ‘weight loss drugs’, ‘weight-reducing drugs’, ‘slimming drugs’, ‘anorectic agents’, and ‘counterfeit anorexics’. Legislation related to anorectics was obtained from the portals of various government and international agencies. Results Anorectics frequently profiled in counterfeit slimming formulations are mostly amphetamine derivatives or its analogues. Five routinely reported pharmacological classes of adulterants, namely anxiolytics, diuretics, antidepressants, laxatives, and stimulants, are mainly utilised as coadjuvants in fake weigh-reducing formulations to increase bioavailability or to minimise anticipated side effects. Liquid and gas chromatography coupled with mass spectrometric detectors are predominantly used techniques for anorectic analysis due to the possibility of obtaining detailed information of adulterants. However, interference from the complex sample matrices of these fake products limits the accuracy of these methods and requires robust sample preparation methods for enhanced sensitivity and selectivity. The most common anorectics found in counterfeit slimming medicines are either completely banned or available by prescription only, in many countries. Conclusions Slimming formulations doped with anorectic cocktails to boost their weight-reducing efficacy are not uncommon. Liquid chromatography combined with mass spectrometry remains the gold standard for counterfeit drug analysis, and requires improved preconcentration methods for rapid and quantitative identification of specific chemical constituents. Extensive method development and validation, targeted at refining existing techniques while developing new ones, is expected to improve the analytical profiling of counterfeit anorectics significantly.

U-47700 and Its Analogs: Non-Fentanyl Synthetic Opioids Impacting the Recreational Drug Market

The recreational use of opioid drugs is a global threat to public health and safety. In particular, an epidemic of opioid overdose fatalities is being driven by illicitly manufactured fentanyl, while novel synthetic opioids (NSOs) are appearing on recreational drug markets as standalone products, adulterants in heroin, or ingredients in counterfeit drug preparations. Trans-3,4-dichloro-N-[2-(dimethylamino)cyclohexyl]-N-methylbenzamide (U-47700) is a prime example of a non-fentanyl NSO that is associated with numerous intoxications and fatalities. Here, we review the medicinal chemistry, preclinical pharmacology, clandestine availability, methods for detection, and forensic toxicology of U-47700 and its analogs. An up-to-date summary of the human cases involving U-47700 intoxication and death are described. The evidence demonstrates that U-47700 is a potent μ-opioid receptor agonist, which poses a serious risk for overdosing and death. However, most analogs of U-47700 appear to be less potent and have been detected infrequently in forensic specimens. U-47700 represents a classic example of how chemical entities from the medicinal chemistry or patent literature can be diverted for use in recreational drug markets. Lessons learned from the experiences with U-47700 can inform scientists, clinicians, and policymakers who are involved with responding to the spread and impact of NSOs.

Internet of Things Based Blockchain for Temperature Monitoring and Counterfeit Pharmaceutical Prevention

The top priority of today’s healthcare system is delivering medicine directly from the manufacturer to end-user. The pharmaceutical supply chain involves some level of commingling of a collection of stakeholders such as distributors, manufacturers, wholesalers, and customers. The biggest challenge associated with this supply chain is temperature monitoring as well as counterfeit drug prevention. Many drugs and vaccines remain viable within a specific range of temperatures. If exposed beyond this temperature range, the medicine no longer works as intended. In this paper, an Internet of Things (IoT) sensor-based blockchain framework is proposed that tracks and traces drugs as they pass slowly through the entire supply chain. On the one hand, these new technologies of blockchain and IoT sensors play an essential role in supply chain management. On the other hand, they also pose new challenges of security for resource-constrained IoT devices and blockchain scalability issues to handle this IoT sensor-based information. In this paper, our primary focus is on improving classic blockchain systems to make it suitable for IoT based supply chain management, and as a secondary focus, applying these new promising technologies to enable a viable smart healthcare ecosystem through a drug supply chain.

Benefit and Challenge of Blockchain Technology in Pharmaceutical Supply Chain Management

Pharmaceutical Industry Supply Chain Management (SCM) has been an invigorating research topic because the industry strives to explore innovative ways to secure the medicine distribution and to ensure the authenticity of medicine consumed by the patients. A surge in the counterfeit drug has called an urgent effort for the industry to eradicate. In this scope, the fake medicine harm serious health problem for patients. To cope with this urgency, Blockchain offers the new innovative technology that captures the security and accountability in the financial industry for decades. In this spectrum, the new generation of blockchain with smart contract feature enables the utilization of blockchain in an enterprise setting such as Supply Chain Management Systems. In this point, this study explored contemporary for benefit and challenge blockchain adoption based on Systematic Literature Review methodology. At a closer look, the research indicates the impact of the Blockchain Adoption Technology in Pharmaceutical Industry SCM in for four aspects, i.e. supplier, producer, logistic/distributor, and customer. In a specific range, this research explores significant factors from ten leading journals (one thousand two hundred and fourteen papers) and selects solely eighteen relevant documents. The examination reveals the critical research development of blockchain technology adoption in Pharmaceutical SCM and twenty-three essential factors.

A questionnaire-based study on knowledge and attitude towards counterfeit medication among the doctors in tertiary care hospital

Background: Counterfeit drugs are a global problem and suffered almost all developing and developed countries worldwide. In India, it is a major problem which results life threatening issues as well as financial loss on health system. So, we conducted a cross sectional questionnaire-based study on knowledge and exposure to counterfeit drugs of doctors at SHKM Govt. Medical College, Nuh, Haryana, India.Methods: A structured questionnaire was distributed to 100 registered doctors. The questionnaire was based on knowledge, attitude and its consequence on the heath system by the practices of counterfeit medication.Results: There were Twenty questionnaires excluded from the study due to incomplete information. Only 57.77% (46/80) subjects having the knowledge of questionnaire correct meaning of counterfeit drug. However, almost 90% (72/80) subjects were aware about its dangerous effects. More than 50% of the subjects have suggested that modern technology is capable to control counterfeiting of the medicine.Conclusions: Counterfeit drugs create a people health hazard and waste to consumer income. The proper knowledge, awareness and modern technological approaches are the devices may helpful in diminution of counterfeit medication practices.

Evaluating the Impacts of Automation on Disrupting the Counterfeit Drug Supply Chain

Counterfeit drugs have become a menace and a dangerous problem for human kind in recent years. The complex nature of pharmaceutical supply chain has made it difficult to control the proliferation of counterfeit drugs being consumed along with the regular drugs. The pharmaceutical industry needs to come up with answers to protect public health, minimize supplier risk, protect brand reputation and promote the integrity of the supply chain. In its report on “Combating Counterfeit Drugs” the US Food and Drug Administration (FDA) concluded that RFID tagging appeared to be “the most promising approach to reliable product tracking and tracing.” (FDA, 2004).[3] In this paper, we will explore how counterfeit pharmaceuticals are finding their way into the supply chain, the consequences experienced on a patient level as a result of counterfeit medicine consumption and more importantly how RFID is of help in fighting this global crime efficiently. RFID (Radio Frequency Identification) has brought a revolutionary change in many industries, especially in supply chain management. Implementing RFID in pharmaceutical industry is a game changer for the pharmaceutical industry because of the ability it provides to efficiently and effectively track medicines from origin to customer, resulting in an overall reduction of the entrance of medicinal counterfeit items in to the supply chain. Not only will RFID technology use benefit the health industry, but also those at the warehouse level, by eliminating the manual work required when using barcodes.