Counterfeit Drugs Research Articles

Blockchain applications in drug data records

Blockchain is a data storage technique in the form of blocks where the hash system and blocks that cannot be manipulated make blockchain suitable for storing important data. One of them is drug data, where currently in drug data, data manipulation often occurs which leads to drug counterfeiting. From previous research, blockchain in the medical world has been applied in storing patient history by utilizing smart contracts. Goals of blockchain application, drug data from manufacturers can be directly viewed and purchased by buyers. The research more towards innovation, blockchain as a database for storing drug data. Ethereum blockchain can be implemented and stored data can be well integrated with Smart Contract. The existence of smart contracts that support and facilitate transactions between producers and buyers. To maintain data security, system will be implementing access permissions in smart contracts to maintain data integrity and security. Eventually maintaining privacy, decentralization, transparency, and authentication in drug data and every drug transaction can be implemented properly.

Adoption of Blockchain Technology in Pharmaceutical Supply Chain to fight Counterfeit Medicine Market

Blockchain Technology (BT) is recognized as a technology with multiple applications in many industries due to the nature of its utilization. In the pharmaceutical industry, an effective supply chain is crucial to mitigate the counterfeit medicine market, which is currently a big challenge, especially for low or middle-income countries. This research investigates the possibility of implementing blockchain technology solutions in Pakistan’s pharmaceutical industry by introducing blockchain Application Software. The pharmaceutical industry and General Practitioners from hospitals and clinics were interviewed in the public and private sectors to understand this possibility. Data coding was conducted on the data gathered from the interviews, and from these codes, categories were extracted, these categories were then further refined to extract the final themes. Finally, the paper discusses that based on the need of the current situation, the proposed BT system would present a solution for making the pharmaceutical supply chain more transparent.

Presence of counterfeit miedicines in Peru 2015-2019: socioeconomic and public health consequences

Objective. To determine the amount of counterfeit drugs admitted to the National Center for Quality Control of the National Institute of Health during the period 2015-2019 and the socioeconomic and public health consequences in our society. Methods. The analysis of the information collected corresponds to counterfeit medicines. This information was processed in a structured spreadsheet with the necessary parameters. Results. Counterfeit medicines in relation to the total medicines analyzed were: 5.7; 7.2; 4.9; 17.0 and 13.3% in 2015, 2016, 2017, 2018 and 2019 respectively. Of 547 counterfeit medicines, according to the ATC Classification, the following therapeutic subgroups stand out: anti-inflammatory and antirheumatic products (22.1%) and antibacterials for systemic use (16.5%). The predominant form of counterfeiting was medicines without an active ingredient (38.6%), followed by those with the correct dose of the active ingredient but from a manufacturer other than the one declared (36.9%). The predominantly counterfeit dosage forms were tablets (69.7%), injectables (8.2%), and capsules (6.8%). 43.7% of counterfeit medicines were of unknown origin. Conclusions. The presence of 8.5% of counterfeit medicines in our country is a problem that not only affects public health, but also causes considerable economic losses, US$177 million per year, and unemployment, 8,791 jobs per year. Metropolitan Lima with 71.7%, continues to be the main focus of the commercialization of counterfeit medicines; whose existence not only occurs in informal markets, but prevails in formal markets. The contribution of this study seeks to be able to develop multisectoral policies that allow stopping the commercialization of these products that represent a scourge in our country.

The perceived influence of COVID-19 lockdown on the circulation of counterfeit drugs and medical supplies through the electronic market

AbstractObjectivesDrugs and medical supplies counterfeiting is one of the worldwide major problems that pose a significant threat to both global public health and the economy. Nowadays, one of the major unprecedented challenges of the COVID-19 pandemic is the disastrous repercussions on the economy worldwide. The latter brought forth a noticeable rise in pharmaceutical and medical counterfeit products. Drug counterfeiting has thrived parallel to the expansion of electronic networks and the Internet during the COVID-19 pandemic. The objective of the current study is to explore the perceived influence of the COVID-19 lockdown on the circulation of counterfeit drugs and medical supplies through the electronic market in Jordan.MethodsA cross-sectional survey study was conducted in Jordan. The questionnaire was self-administered to the public as they are the probable counterfeit medicine victims and as drug counterfeiting is a nationwide problem. To capture participants’ views, a total of 460 respondents were recruited and a simple random sampling strategy was used to collect data. The inclusion criteria were consumers aged 18 years old and above, who use the Internet when purchasing drugs and medical supplies, and are willing to participate in the study.Key findingsThe study indicated an increase in using electronic websites when purchasing medicines during the COVID-19 lockdown. Additionally, there was a significant correlation the between COVID-19 lockdown and the circulation of counterfeit drugs and medical supplies through the electronic market in Jordan.ConclusionsThe study indicated that the COVID-19 lockdown had influenced counterfeit drugs and medical supplies circulation through the electronic market in Jordan.

Challenges Associated with Addressing Counterfeit Medicines in Nigeria: An Exploration of Pharmacists' Knowledge, Practices, and Perceptions.

Counterfeit medicines are substandard pharmaceutical products that are produced and sold with the intent to deceptively represent their authenticity, origin, or effectiveness. The risk of the existence of such products in healthcare provision remains a significant threat to public health. Pharmacists represent the most critical stakeholders in the supply, manufacture, purchase, and dispensing of pharmaceutical products, and as such can play critical roles in detecting and reducing the circulation of fake medicines. This study aimed to assess the knowledge and practices of pharmacists in Nigeria in relation to counterfeit medicines as well as the challenges associated with preventing and mitigating this menace in the country. A cross-sectional study was undertaken to administer questionnaires to pharmacists across various sectors of practice in Nigeria. Data were analysed using Statistical Package for Social Sciences. A total of 390 valid responses were received. The respondents indicated that online drug commerce (72.68%), inadequate inspection (90.93%), inadequate legislation (88.83%), poor collaboration (89.94%), and poor cross-border enforcement (90.43%) were primary challenges to the mitigation of fake medicines circulation in the country. Whilst pharmacists were knowledgeable about counterfeit drugs, gaps were observed in their practices towards detection of these products, as about one-third (30.7%) of the sample indicated that their current knowledge and skills were inadequate to detect counterfeit medicines. Age, years of practice, and area of practice significantly influenced the abilities of the participants to detect counterfeit medicines. Evidence from the study revealed that pharmacists had good knowledge of medicine counterfeiting in Nigeria. However, factors such as poor collaboration among regulatory agencies, inadequate inspection and legislation on the regulation of the pharmaceutical sector and online sales of medicines have contributed to the circulation of counterfeit medicines, and this has in turn affected healthcare services in the country.

Economic Evaluation: Advantages of Implementing Drug Track and Trace beyond Health Benefits

Traceability is a valuable strategy to prevent the administration of counterfeit and substandard medicines, but despite being an efficient risk management strategy, it has high implementation and operational costs. An economic evaluation, taken with the identification of risks to be mitigated, potential benefits, related costs, and ways to fund the project implementation and operationalization, can determine the feasibility of a traceability model. This evaluation admits different perspectives depending on the stakeholder. Several countries are working on different traceability and financing models according to identified risks, expected gains, and economic impacts. This opinion paper describes the problem, track and trace models mostly adopted, most used economic evaluation methods in healthcare, and defines the hypothesis that investment return can enable the decision-making for a drug track system implementation.

The Present Policy of the National Health Care System in Sudan

The strategy of price liberalisation and privatisation had been implemented in Sudan over the last decade and has had a positive result on government deficit. The investment law approved recently has good statements and rules on the above strategy in particular to pharmacy regulations. Under the pressure of the new privatisation policy, the government introduced radical changes in the pharmacy regulations. To improve the effectiveness of the public pharmacy, resources should be switched towards areas of need, reducing inequalities and promoting better health conditions. Medicines are financed either through cost sharing or full private. The role of the private services is significant. A review of reform of financing medicines in Sudan is given in this study. Also, it highlights the current drug supply system in the public sector, which is currently responsibility of the Central Medical Supplies Public Corporation (CMS). In Sudan, the researchers did not identify any rigorous evaluations or quantitative studies about the impact of drug regulations on the quality of medicines and how to protect public health against counterfeit or low-quality medicines, although it is practically possible. However, the regulations must be continually evaluated to ensure the public health is protected against by marketing high quality medicines rather than commercial interests, and the drug companies are held accountable for their conduct.

PENGENALAN DAGUSIBU OBAT BERSAMA PKK KELURAHAN/KECAMATAN KARANGREJO KABUPATEN MAGETAN

Knowledge of medicine is a must for all levels of society. DAGUSIBU is one of those attempts to increase public knowledge in using and managing drugs amidst the widespread of counterfeit drugs and drugs abuse. The purpose of this community service is to provide DAGUSIBU counseling to the community, especially PKK in the Karangrejo Sub-district, Magetan Regency. This counseling is expected to increase knowledge of the use of drugs. Participants in this counseling were given material about DAGUSIBU directly and supported by teaching aids in the form of medicine as an example of the application of DAGUSIBU in active discussion. The result achieved is the increase in this counseling participants about drugs through DAGUSIBU by 44.31% from 46.27 to 90.59 forming DAGUSIBU cadres in the community. Therefore, this counseling needs to be continued to improve cadres as quality information agents to the general public, especially in the Karangrejo Sub-district, Magetan Regency

Framing access to essential medicines in the context of Universal Health Coverage: a critical analysis of health sector strategic plans from eight countries in the WHO African region

BackgroundFraming affects how issues are understood and portrayed. This profoundly shapes the construction of social problems and how policy options are considered. While access to essential medicines (ATM) in the World Health Organization (WHO) African Region is often framed as a societal problem, there is dominance of medical and technically oriented approaches to analyze and remedy the situation. Hence, the systematic application of social science approaches, such as framing theory, remains under-explored. Through a framing analysis of National Strategic Plans (NSPs) from eight countries, this study explores the applicability and potential usefulness of framing theory to analyze essential medicines policies.MethodsWe inductively coded the relevant NSP textual fragments using the qualitative content analysis software ATLAS.ti.22. Benford and Snow’s conceptualization of framing was used to organize the coded data into three frames: diagnostic (problems), prognostic (solutions) and motivational (values and ideological).ResultsThe following five diagnostic frames were dominant or in-frame: medicine unavailability, ineffective regulation, weak supply chain management, proliferation of counterfeit (substandard or falsified) medicines and use of poor quality medicines. Diagnostic frames related to financing, affordability, efficiency and corruption were given limited coverage or out of frame. Prognostic frames corresponded with how these problems were framed. Whilst Universal Health Coverage (UHC) and its guiding principles was the dominant motivational frame, we identified some frame discordance between the global discourse and national level policies.ConclusionsSocial science approaches such as framing analysis are applicable and useful to systematically analyze essential medicine aspects. By applying framing theory, we revealed that ATM aspects in the eight countries we analyzed are more often characterized in relation to availability at the expense of affordability which undermines UHC. We conclude that whilst UHC is a strong motivational frame to guide ATM aspects, it is insufficient to inform a comprehensive approach to address the problems related to ATM at country level. To effectively advance ATM, concerned actors need to realize such limitation and endeavor to gain a deeper understanding of how problems are framed and agendas are set at country level, the processes through which ideas and knowledge become policies, including the political demands, incentives and trade-offs facing decision-makers in selecting policy priorities.

Awareness of Counterfeit Medicine among Saudi University Students

Background: Lack of knowledge and awareness of the society is one of the major contributing factors to the prevalence of counterfeit medicines in a country. There is limited information in the developing countries on university student’s facts concerning counterfeit medicines.
 Aim: To assess how the university student either in medial or non-medical colleges identify counterfeit and substandard medicines and to evaluate their vulnerability level toward counterfeit drugs.
 Methods: Structure electronic questionnaire was distributed in Saudi Arabia, between December 2020 till March 2022. The sample included 1216 respondents selected conveniently from two distinct groups (Student in either medical or non-medical colleges). 1204 participants who were fluent in either English or Arabic were included. The objective of this study is to give better understanding of counterfeiting in drugs and how to fight it.
 Results: From one thousand two hundred and sixteen questionnaires were distributed to university student both medical college and non-medical college, only 12 were refused to participate, which indicate higher in response rate. 85% of the answers were female, 36% below 20 and 92% of them were Saudi citizen wit 67% single state. Most of the results of the survey (38 items) were insignificant (p-value>0.05) only 13 (34%) question of the survey relived significant. So, more awareness towards counterfeit medicines, in the level of university student will needed reduce the lack of knowledge.
 Conclusion: Although medical school students have higher knowledge about counterfeit drugs, nevertheless, the overall findings suggested low-level of knowledge, exposure to counterfeit were estimate in both medical and non-medical college students in most of the surveyed items.

Physicochemical Equivalence and Quality Assessment of Various Brands of Gastro-Resistant Omeprazole Capsules in the Kumasi Metropolis.

The proliferation of counterfeit and poor-quality drugs is a major public health problem, especially in developing countries such as Ghana where there are inadequate resources to effectively monitor their prevalence. Most of these drugs, which are counterfeited, are drugs, which are in high demand and will reap huge profits for the unscrupulous people who engage in such activities. The introduction of Omeprazole as one of the first-line therapies in the management of peptic and duodenal ulcers in the treatment guidelines of Ghana has resulted in many generics being introduced onto the market. The pharmaceutical quality of fifteen randomly sampled Omeprazole capsule brands in the Kumasi metropolis was assessed using the innovator brand as a comparator to confirm their suitability for patient use and to provide data for drug regulatory agencies in Ghana concerning poor quality omeprazole brands. All the sampled brands complied with the official specifications for identification with good primary and secondary packaging characteristics. Ninety-four (94%) of the sampled brands passed the uniformity of weight test. All the brands (n = 16) representing 100% passed the disintegration tests. Sixty percent (60%) of the sampled brands passed the drug content test. Ten brands (66.7%) met the specification for in vitro dissolution test. From f2 analysis, the dissolution profiles of only five brands (31%) were similar to that of the reference brand which indicated that they could be used interchangeably in clinical practice. Conclusively, ten out of the fifteen sampled brands were of good quality and only five could be used as a substitute for the innovator. Thus, regulatory agencies will need to strengthen their postmarket surveillance to ensure that generic brands of good quality are allowed onto the market.

Blockchain technology and vaccine supply chain: Exploration and analysis of the adoption barriers in the Indian context

The vaccine distribution system, being a bio-pharmaceutical cold chain, is a complicated and sensitive system that must be effectively managed and maintained due to its direct impact on public health. However, vaccine supply chains continue to be affected by concerns, including vaccine expiry, inclusion of counterfeit vaccines, and vaccine record fraud. The blockchain technology integrated with the Internet of Things (IoT) can create a solution for global vaccine distributions with improved trust, transparency, traceability, and data management, which will help monitor the cold chain, tackle counterfeit drugs, surveillance, and waste management. Several theoretical models for vaccine management with blockchain have recently been published, and a few pilot studies for COVID-19 vaccine management using blockchain have been started in India. Still, full-scale adoption of blockchain technology in vaccine distribution and management has yet to be achieved due to underlying barriers. This study explores the adoption barriers utilizing Technology-Organization-Environment (TOE) framework with the help of extant literature and inputs from administrators, academics, immunization, and blockchain experts and then analyzed using the Delphi and fuzzy Decision-Making Trial and Evaluation Laboratory (DEMATEL) techniques. The finding shows that the requirement of change in organizational structure and policies is the most prominent barrier, and the barrier related to requirement of large-scale IoT infrastructure and lack of technical expertise are the most impactful barriers. The theoretical contribution of this study lies in the identification and analysis of barriers that should be addressed to achieve blockchain technology adoption in the vaccine supply chain.

Blockchain Technology based Smart Contract Model in Indonesia

The primary task of integrated product supply chain management is distribution. The processing, storage, and distribution of high-quality pharmaceutical products makes the drug distribution process crucial in the pharmaceutical sector. The distribution of fake medications by associated parties, such as unauthorized or unregistered distributors or data collecting for unregistered medications distributed by distributors, is a concern in the pharmaceutical industry. Drug production permits that are misused up until they are distributed or circulated do not adhere to the Food and Drug Supervisory Agencies standard requirements. In order to facilitate the distribution process by recording data distribution, providing data security, and giving traceability of transactions between linked parties, these issues must be rapidly resolved with technology help. By utilizing blockchain technology, this study suggests a beneficial medicine delivery approach. A user-centered design and a qualitative methodology are used in the model creation. This study's output is a blockchain-based drug delivery mechanism that has been verified. Transparency, security, traceability, decentralization, automation, immutability, and reliability are all features of the model. By ensuring that the pharmaceuticals supplied are of high quality, this strategy can assist the government in promoting community safety, health, and trust in the drugs that are in use.

Blockchain concept to combat drug counterfeiting by increasing supply chain visibility

ABSTRACT This paper explores problems of pharmaceutical supply chains, such as drug counterfeiting, and the opportunities of using digital technologies to overcome them. It also evaluates the risks associated with the use of digital technologies. Expert interviews were conducted with pharmaceutical supply chain stakeholders in the first step. The data obtained was assessed through qualitative content analysis. In addition to the lack of transparency, strong individual interests of the supply chain actors and different implementation levels of digitisation were revealed. It is also noticeable that the industry is still paper-oriented. Nevertheless, the chosen experts are optimistic about the increased use of digital technologies. Combining blockchain with other technologies, such as IoT and AI, can improve efficiency, traceability, and trust in pharmaceutical supply chains. A digitalised supply chain concept is developed based on these technologies, enhancing transparency and information availability in the supply chain. In addition, communication and processes along the entire pharmaceutical supply chain are optimised.

Supply chain risk factor assessment of Indian pharmaceutical industry for performance improvement

PurposeThe purpose of the present work is to improve the industry performance by identifying and quantifying the risks faced by the Indian pharmaceutical industry (IPI). The risk values for the prominent risks and overall industry are determined based on the four risk parameters, which would help determine the most contributive risks for mitigation.Design/methodology/approachAn extensive literature survey was done to identify the risks, which were also validated by industry experts. The finalized risks were then evaluated using the fuzzy synthetic evaluation (FSE) method, which is the most suitable approach for the risk assessment with parameters having a set of different risk levels.FindingsThe three most contributive sub-risks are counterfeit drugs, demand fluctuations and loss of customers due to partners' poor service performance, while the main risks obtained are demand, financial and logistics. Also, the overall risk value indicates that the industry faces medium to high risk.Practical implicationsThe study identifies the critical risks which need to be mitigated for an efficient industry. The industry is most vulnerable to the demand risk category. Therefore, the managers should minimize this risk by mitigating its sub-risks, like demand fluctuations, bullwhip effect, etc. Another critical sub-risk, the counterfeit risk, should be managed by adopting advanced technologies like blockchain, artificial intelligence, etc.Originality/valueThere is insufficient literature focusing on risk quantification. Therefore, this work addresses this gap and obtains the industry's most critical risks. It also discusses suitable mitigation strategies for better industry performance.

Legal Responsibility for Illicit Trade in Pharmaceuticals under Conditions of the Covid-19 Pandemic

The aim of this study was to examine the optimal types and measures of legal liability for crimes in the field of illicit trade in pharmaceuticals in the conditions of the СОVID-19 pandemic. The research used methods of systematic approach, descriptive analysis, synthesis and prognosis, systematic and formal legal and comparative selection. It has been established that illicit trade in pharmaceuticals is carried out by organized criminal groups and is related to corruption and cybercrime. Also, the article has revealed typical legal flaws, which complicate international cooperation in this field and lead to non-compliance with international standards of criminalization and imposition of sanctions for illegal circulation of counterfeit medicines. All this leads to the conclusion that the illicit trade in pharmaceuticals manifests itself in a series of offenses for which administrative or criminal liability must be foreseen. Equally promising is the development of a model for law enforcement activity that includes criminalization of trade in low-quality, unregistered and counterfeit pharmaceuticals, according to international standards; proportional punishments for natural persons and influence measures for legal persons and compensation for their victims.

Disruptive e-prevention from 2019: dummy online drug selling sites to reach new consumers

Abstract Background The last three decades have seen the development of chemsex, the diversification of substances through New Psychoactive Substances (NPS), and new technologies allowing people to buy online and find peers to consume on applications while remaining in private spheres (Trend, Cadet-Taillou, 2020). The latter has made it more difficult to reach users, so as to document their uses and the population, and to design public health schemes aimed at users, except through targeting metapopulations known to consume more than the general population (Léobon et al., 2018; Talley et al., 2011). Methods The PlaySafe association designed two dummy websites, one selling GBL, the other NPS. These websites use the same graphics and syntactic codes as the main websites of the field, except for: 1) a fake drug named “love machine”; 2) an automatic redirection to a health promotion page instead of payment finalization. The information collected is: delivery region, birth year, gender, perceived usefulness of the health promotion messages, whether people would recommend to friends, the contents and quantities of the shopping cart, the time spent on each page, and data gathered via Google Analytics. Results On both websites 21,459 order attempts have been placed. This pathfinder research project has allowed to reach 6,203 people on the GBL website in 30 months and 7,927 people in 12 months on the NPS website, with people spending on average 1 min 35 s on the first website's prevention page and 1 min 27 s on the second. Around 85% of people consider the content useful, among whom 75% would recommend the website to friends. This communication also aims to present the characteristics of the reached population. Conclusions This innovative approach has allowed to precisely target a population escaping public health research and prevention schemes. It appears interesting to explore online prevention, especially since most of the respondents consider the experience helpful and recommendable. Key messages

Heat Pulse Desorption of Low-Volatility Compounds by a Heated N2 Gas Pulse with Mass Spectrometry.

For the thermal desorption of low-volatility compounds, rapid heating followed by instant cooling is desirable to suppress thermal decomposition. In this work, a new thermal desorption method, heat pulse desorption (HPD), was developed. A heated N2 gas pulse (350 °C, 50 ms) was directed to the solid sample surface, and desorbed analytes were ionized by DC corona discharge and mass analyzed by an Orbitrap mass spectrometer. Because heat transfer from the heated N2 gas to the solid surface is not very efficient, desorption of the solid sample occurs at a certain temperature before reaching 350 °C. In short, there is a self-controlling desorption depending on the volatility of each analyte. Because the exit of the copper tube for gas blowing is separated from the sample surface, no carryover occurs, enabling the repetitive analysis of samples. HPD was applied to various compounds such as narcotics, pharmaceutical tablets, and explosives. Because analysis is completed within a few seconds per sample, this method is highly useful for quick and consecutive analysis of real samples, having potential utility in food quality control, counterfeit drugs analysis, and the detection of explosives for safety and security.

A systematic review of the literature on the application of blockchain in the health supply chain

Objective of the study: This article aims to present a systematic literature review on the application of blockchain in the healthcare supply chain.Relevance / originality: The relevance and originality consist in the presentation of a systematic literature review that focuses and considers the concepts of blockchain, healthcare and supply chain as equally important, in the studied time frame.Methodology / approach: The systematic literature review followed a protocol based on Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA), performing the search in eight databases, selecting conference and journal articles based on their content in sequential steps.Main results: As a result, 122 publications were selected. The number of publications in the field has been found to grow rapidly, and sensors and the Internet of Things (IoT) are two prominent minor topics. Three research challenges were raised.Theoretical / methodological contributions: Provide understanding to academics and professionals in the field about the state of the art of applying the blockchain in the healthcare supply chain, both in terms of the evolution of the literature, as well as in terms of raising new research.Social / management contributions: Raising discussions on solutions to healthcare supply chain issues, involving for example data integrity and privacy in electronic medical reports, drug counterfeiting and the use of sensors and the internet of things.

Blockchain Technology - A Algorithm for Drug Serialization

The Blockchain technology uses different type of database that transact data in blocks and then chained each data blocks. When data fills one block, it is chained the same data onto previous block therefore, all the data blocks are stored in chronological order. The blockchain technology can help to ensure that data in supply chain is reliable, accurate and can be shared with all stakeholders without any manipulation. It makes supply chain more transparent and end-to-end digital visibility of data source. Blockchain is stringent technology which fill the gap between stakeholders by providing transparent unmanipulated and truthful data in supply chain. There are many initiatives has been taken by multiple regulatory bodies with partnering with supply chain stakeholders including pharmaceutical manufacturer, distributors and dispensers. In USA, Food and Drug Administration’s regulatory body Drug Supply Chain Security Act (DSCSA) initiated pilot program in 2019 with the partnership of leading pharmaceuticals distributors to authenticating saleable returns to distributor from supply chain partners. DSCSA used MediLedger blockchain interoperable technology for process evaluation and it robustness for mitigating risk of drug counterfeiting possibilities in supply chain. The DSCSA found that pilot project was successful and results were astonishing. Later it was declared that blockchain technology can also be used for meeting DSCSA’s 2023 Act for unit level traceability.