The journal co-citation analysis was performed. Figure 3 is a co-citation analysis of highly co-cited journals. Research on SF medical products mainly emerges from the convergence of research conducted in pharmaceutical analysis, public health, and infectious diseases. The red cluster integrates journals on medicine, public health, and infectious disease. The blue cluster represents the contribution of chemistry, chromatography, and pharmaceutical journals.
Clusters represent the scientific disciplines underlying the emergence of the SF medical products scientific research. Figure 4 shows the major topics of research on SF drugs during the past 60 years. The map is a co-occurrence analysis of author keywords. The size of the nodes indicates the frequency of occurrence of keywords while the thickness of connecting lines represents the co-occurrence strength between pairs of keywords.
Different clusters represent major research topics encountered in the retrieved documents. The top-cited documents reflect topics that are considered hotspots in the field and received the highest citations. The 10 most impactful research articles and the 10 most impactful review articles were listed in Appendix 3. The research article that received the highest number of citations was published in the ChemMedChem journal and discussed the chemical technique for the detection of fake medicines.
The research article that received the highest rate of citations number of citations per year was published in Nanoscale journal and discussed the use of inkjet printing as an anti-counterfeiting strategy.
The review article that received the highest number of citations was published in The Lancet Infectious Disease while the review article that received the highest rate of citations number of citations per year was published in Expert Opinion on Drug Safety journal and discussed the emerging technologies to combat fake medicines. Analysis of funding showed that The main funding sponsor was the U.
The present study aimed to analyze global research publications on SF medical products using a bibliometric methodology. The growth of publications on SF medicines was influenced by the milestone initiatives by international organizations to fight falsified medicines [ 5 ].
The beginning of the second growth phase of publications coincides with the first international conference on counterfeit medicines launched in while the third phase coincides with the publication of the technical briefing by the World Health Assembly WHA in The overall growth of publications seen in the last decade was also attributed to the sale of fake medicines through online pharmacies [ 27 , 28 ] and the trafficking of falsified medicines across borders in countries with regulatory policies in this regard [ 29 , 30 ].
The list of core journals has two journals, Lancet and BMJ, that are related to the public health domain. Falsified medicines have been described as a threat to public safety and health [ 31 ]. The spread of certain fake drugs used for malaria or cancer causes serious health, economic, and humanitarian harm [ 32 , 33 ].
The use of falsified antimicrobial agents has serious public health implications including the rapid emergence of antimicrobial resistance with poor infection control [ 34 ]. The use of falsified or substandard cardiovascular drugs such as clopidogrel could increase the risk of morbidity and mortality in high-risk patients [ 35 ].
Another serious public health problem of SF medical products emerged with the spread of fake coronavirus vaccines in certain parts of the world [ 36 , 37 ]. The productivity analysis for authors and countries indicated that research on SF medical products occurs in a large number of countries. The leading role of the US and certain European countries was not surprising since 1 it is in those countries where better infrastructures and more abundant resources for research are available [ 38 ]; 2 well-established and major pharmaceutical companies exist, and 3 falsified medicines is a global problem and present in developed countries as well as developing ones.
India and China ranked 6th and 7th respectively in research productivity in this field. However, representatives of the Indian pharmaceutical industry disagree with the US allegation and stated that up to 3. Drug regulatory agency in India has implemented regulations specifically to fight falsified drugs [ 30 ].
China took several steps in the fight against falsified drugs especially after the death of more than a dozen infants in China due to fake milk powder that had little or no nutritional value [ 40 ]. Falsification of medicines is an old phenomenon [ 42 ] and affects people in all income categories. However, the problem tends to be more obvious in world regions with 1 intense cross-border movements, 2 high demand for less expensive drugs, and 3 weak national regulatory policies on the manufacturing and marketing of medications.
One example is the spread of low-quality antimalarials in the Greater Mekong Subregion. Reports indicated that the use of falsified and substandard antimalarials in the Mekong region led to artemisinin resistance, creating new challenges for the eradication of malaria [ 43 , 44 , 45 ].
Except for collaboration between researchers in the US and the UK with researchers in the Mekong region Laos, Thailand, and Cambodia , the present study showed limited research collaboration at the author and cross-country levels. International research collaboration is considered one potential mechanism for enhancing the social and scientific relationship between countries [ 48 ].
The research collaboration with countries in the Mekong region was based on the problem of border malaria and the urgency of eliminating artemisinin-resistant P. One approach by the WHO to eliminate malaria from the Mekong area by depends on fighting cross-border trafficking of substandard and falsified antimalarial drugs. In the present study, research collaboration was observed between France and certain countries in Africa including Benin, Congo, and Burkina Faso.
Falsified medicines are present in many African countries [ 9 , 50 ] and the prevalence of substandard antimalarials was reported to be as high as In most cases of falsified medicines in these regions, the problem was in low amounts of active pharmaceutical ingredients [ 52 ]. The research collaboration with countries in the South-East Asia region was stronger than that with African countries possibly because of the serious threat of the emergence of anti-malarial drug resistance in the Mekong region [ 53 , 54 ].
Analysis of keyword co-occurrences indicated that falsified antimalarial drugs constituted a separate research topic. This was expected given that malaria is a major public health threat with more than million affected people in Africa and the South-East Asian region [ 55 ]. The same study reported that counterfeit Viagra usually came from non-U. Websites and social media are new powerful instruments to sell fake medicines and generate profit [ 57 ].
A large number of publications on counterfeit Viagra and other sexual stimulants were dedicated to the development of detection technologies [ 29 ].
It has been suggested to use blockchain technology as well as strengthening regulatory bodies and policies to fight the internet pharmaceutical trade [ 58 ]. The use of detection technology such as chromatography and spectrophotometry constituted another research topic in the retrieved documents.
Such technologies are in use to detect falsified medications, especially in developing countries [ 29 ]. Collaboration between governments and the pharmaceutical industry is needed in the fight against falsified medicines.
It has been argued that several countries and pharmaceutical companies tend to hide news about fake drugs to avoid national panic or because of their inability to fight the phenomenon [ 59 ].
Strengthening the role of pharmacovigilance centers is also needed in the coordinated fight against falsified medicines.
When considering adverse drug reactions, pharmacovigilance personnel need to consider the source of the drug especially the internet sources. The current study has several implications on national and international health policy that are summarized below in 10 points.
Research activity on SF medical products enables policymakers and public health experts to quantify the problem and assess its impact on national health security. Furthermore, research on SF medical products allows governments to build anti-counterfeiting strategies based on the types of SF products and the stage at which these products enter the pharmaceutical supply chain.
One important point to strengthen research about SF products is to initiate a national pharmacovigilance center to receive reports about unexpected or low-quality medications. The diethylene glycol poisoning of children in Nigeria is a good example of how reporting and tracing of adulterated chemicals helped uncover the story of the adulterated paracetamol syrup [ 60 , 61 ].
Public health experts need to take into consideration the presence and the spread of SF products to understand and fight global public health problems such as antimicrobial resistance.
Lack of therapeutic benefit and resistance related to antimalarial drugs indeed caught the attention of many researchers.
However, other falsified antimicrobial agents are present in different parts of the world but are either unnoticed or under-researched. Therefore, the authenticity of all types of antimicrobial agents needs to be periodically screened and tested to confirm good quality and the absence of any falsified antimicrobial agents [ 62 ]. The pharmaceutical industry should be fully involved in the fight against falsified drugs.
One reason for the widespread presence of SF drugs is the high prices of certain groups of medications [ 63 ]. The pharmaceutical industry should take the initiative to make their prices more affordable especially in low- and middle-income countries.
The pharmaceutical industry should also launch awareness campaigns to increase the knowledge of the public and those in the healthcare system about the presence of SF products and their health risks. The search on SF products in the past few decades focused on antimicrobial medications and lifestyle medications such as sexual stimulants. However, this does not mean that there are no SF medications used for non-communicable diseases such as anti-cancer drugs and biological drugs.
Future research and screening should include all categories of expensive and life-saving drugs. Counterfeit bevacizumab was present in different countries including the US and India [ 64 , 65 ]. The finding that no research or insignificant research activity was present in different parts of the world such as the African region and the Eastern Mediterranean region does not mean that the problem of SF products in these regions is absent.
Lack of research on SF products mostly suggests the lack of data or research capacity or absence of scholars interested in this field. The opposite is true. Countries with high research activity on SF products are not necessarily suffering from a widespread problem of SF products. Most of the research on SF products in high-income countries is dedicated to developing and implementing anti-counterfeiting policies, regulations, and technologies.
In this regard, countries with reported incidents of falsified medications should develop regulations and strict laws to fight criminals involved in the manufacturing and marketing of SF products. Countries also need to invest in research and technologies needed to fight falsified medicines.
Encouraging research in this field needs funding and training. This is an important area of research collaboration between high-income countries and resource-limited countries with a high burden of diseases and the potential presence of SF products. Investment of high-income countries in such collaboration will reflect positively on the national health of these countries because the widespread presence of SF products has an international dimension and could negatively affect international health security.
Research on SF medical products is of importance to pharmacists, physicians, nurses, public health experts, and policymakers. Therefore, editors of journals in these medical fields should take the initiative and launch a special call for papers on SF products to increase and stimulate the interest of scholars and professionals to write in this field.
Public health journals have a large and diverse number of readers and publishing documents on SF products in these journals will have a positive impact on the fight against falsified drugs. Comparative research on the regulations and laws implemented on criminals involved in the SF products is important to unify the punishment across different countries. Criminals in the field of SF products should not feel secure in any country and should always be held accountable for the potential loss of lives due to these products.
Strict and tough punishments should be implemented across all countries on criminals manufacturing and marketing SF products. Research on the success of various policies implemented by different high-income countries needs to be published to assess the success rate and effectiveness of each policy or group of policies and anti-counterweighting strategies.
Online pharmacies sell falsified medications and can be accessed through an internet connection. Online sales and online advertisements of medications through pop-up windows in social media need better monitoring and control by individuals and the healthcare system of the country.
Websites responsible for the online sale of prescription medications need to be periodically verified and reviewed. There are several new technologies developed for faster and accurate screening and detection of falsified medical products. Investment in the new and updated technologies and research on the accuracy and efficacy of the different technologies implemented in different countries for detection of falsified medications. This created some sort of bias toward countries with journals indexed in Scopus or countries with English publications.
Therefore, research productivity from other world regions might be under-estimated. The current study aimed to analyze and visualize documents published in a peer-reviewed journal on SF medical products. The key findings of the current bibliometric and visualization study are summarized as follows: a there was a steep growth of publications seen after the year ; b the publications were disseminated through a large number of journals, especially those in the field of pharmacy, public health, and chemistry; c authors involved in publishing the retrieved documents were affiliated with a relatively large number of countries, especially the USA and other English-speaking countries; d Cross-country collaboration was observed between developed countries and countries in the Mekong region and Africa; e active authors have limited interaction between them; and f falsified antimalarials and sexual stimulant medications were major therapeutic classes encountered in the retrieved documents.
The current study is meant to stimulate researchers and academics, especially in developing countries, to get involved in this field through research investigation to identify falsified medications and their illegal manufacturing and marketing.
Furthermore, pharmacists, nurses, and physicians need to get involved and report suspected medications to authorities to take firm action.
The author of the current study recommends the following to endorse the safety of patients and global health security. First, research from regions with low research activity is needed and must be encouraged and funded to identify the size of the problem and the types of the therapeutic classes being marketed as falsified drugs.
Second, high-income countries need to support other world regions in terms of building research capacities, training, and funding for scholars in low- and middle-income countries.
Third, research on medications other than antimicrobials is needed especially anti-cancer drugs, biological drugs, and medications used in cardiovascular diseases. Fourth, there is an urgent need for international collaboration in implementing new updated technologies in the detection of SF products.
This requires more research on the most effective methods and technologies. Research on the levels of awareness and extent of participation of pharmacists, nurses, and physicians on the anti-counterfeiting strategies is needed to have a comprehensive national policy in this field. Fifth, all healthcare providers need to be part of the war against SF products by reporting to pharmacovigilance centers about unexpected adverse drug reactions or failure to get the optimum therapeutic outcomes from certain well-known drugs.
Finally, as a future recommendation for policymakers, harsh penalties need to be implemented on criminals involved in SF manufacturing and sale. Counterfeit drugs: guidelines for the development of measures to combat counterfeit drugs. Burns W. WHO launches taskforce to fight counterfeit drugs.
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Interventions to combat or prevent drug counterfeiting: a systematic review. Registration regulation of drugs, raw materials and biologically active substances revised. Download references. Authors would like to acknowledge all directors and staff of participating pharmacy outlets for their help and support to conduct this study.
The funder had no role in the design of the study and collection, analysis, and interpretation of data and in writing the manuscript. Zorig street, Ulaanbaatar, Sukhbaatar District, , Mongolia.
You can also search for this author in PubMed Google Scholar. The authors read and approved the final manuscript. Correspondence to Gereltuya Dorj. Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material.
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BMC Public Health 20, Download citation. Received : 19 February Accepted : 11 May Published : 20 May Anyone you share the following link with will be able to read this content:. Sorry, a shareable link is not currently available for this article.
Provided by the Springer Nature SharedIt content-sharing initiative. Skip to main content. Search all BMC articles Search. Download PDF. Abstract Background High prevalence of falsified, counterfeit and substandard medicines pose a threat to public health and treatment failure. Methods A cross-sectional study collected essential medicines from pharmacy outlets in Mongolia, during June and July, Results A total of samples from pharmacy entities were purchased from wholesalers in urban and rural areas.
Conclusions This study has indicated that falsified and substandard medicines are prevalent in Mongolia. Quality analysis of samples Materials for quality assessment Quality assessment tests including i appearance, ii weight variation, iii hardness, iv friability, v disintegration time and vi assay were determined according to pharmacopoeial methods according to the origin of the product or specification requirements from the manufacturer.
Table 1 Selected drugs and corresponding reference standards Full size table. Full size image. Table 2 Summary data of collected samples, their sources, strengths and dosage forms Full size table. Table 3 Assessment of the outer packaging for regulatory compliance Full size table. Table 4 Number of samples that failed each pharmacopoeial test Full size table.
The Directive came into force on 21 July Member States had to start applying its measures in January This Directive aims to prevent falsified medicines entering the legal supply chain and reaching patients.
It introduces harmonised safety and strengthened control measures across Europe by applying new measures, which can be grouped into four main pillars:. The annexes of the regulation include the list of medicines subject to this requirement. Manufacturers will upload the information contained in the unique identifier for each individual medicine to a central EU repository. The repository is part of an end-to-end medicines verification system introduced by the Regulation.
Depending on the source of the medicine, wholesalers will also need to scan medicines at different points in the supply chain to verify their authenticity. Pharmacies and hospitals will then scan each medicine at the end of the supply chain to verify their authenticity and check them out from the repository before dispensing them to patients.
These safety features will guarantee medicine authenticity for the benefit of patients and businesses, and will strengthen the security of the medicine supply chain, from manufacturers to distributors, pharmacies and hospitals. EMA and the European Commission have prepared an implementation plan, including regulatory requirements and timelines, to guide applicants and marketing authorisation holders of centrally authorised medicines in meeting the requirements:.
EMA has revised the product information templates for human medicines to enable companies to implement the new rules. Supply chain and good distribution practice. The Directive introduces new responsibilities for wholesalers and a definition of brokering activities as well as new responsibilities for brokers.
The Agency's revised good-distribution-practice guideline includes specific provisions for brokering activities.
Active substances and excipients. From July , all active substances manufactured outside the EU and imported into the EU have had to be accompanied by a written confirmation from the regulatory authority of the exporting country.
These statements are issued per manufacturing site and per active substance and ensure that standards of good manufacturing practice GMP equivalent to those in force in the EU are upheld. A number of countries have already committed to issuing written confirmations.
Exporting countries with an 'equivalent' regulatory framework will not need to issue these written confirmations. The European Commission, together with the Agency and Member States, is assessing the regulatory frameworks of countries applying for 'equivalent' status.
The European Commission maintains a webpage detailing the status of the requests received: Quality of medicines and GMP. The Directive has introduced an obligatory logo that will appear on the websites of legally operating online pharmacies and approved retailers in the EU.
The logo will allow patients and consumers to identify authorised online pharmacies and approved retailers providing authentic, authorised medicines. Clicking on the logo will link to the national regulatory authority websites, where all legally operating online pharmacies and approved retailers in their respective countries will be listed.
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