The substantiation of the conceptual model for countering the spread and combating counterfeit medicines and medical products in Ukraine

The problem of drug counterfeiting is global; therefore, it is relevant for all countries of the world. However, the effectiveness combating the spread of counterfeit medicines (CM) differs in different countries, as evidenced by data on the level of counterfeit. Ensuring proper quality control of drugs in all areas of their circulation requires national regulatory authorities to systematically address these urgent problems; primarily, this concerns the pharmaceutical legislation to counteract the spread of counterfeit medicines and medical devices (MD), as well as to implement the effective state policy in this extremely important area that determines the national security of the state.

Combatting Substandard and Falsified Medicines: Public Awareness and Identification of Counterfeit Medications

Objectives: The objective of this study was to determine the identification rate of substandard and falsified medications and its association with knowledge among public.Methods: This descriptive cross-sectional study was conducted in different geographic areas among a convenient sample of people aged 18 or older. A validated web-based electronic questionnaire was used for data collection tool. The questionnaire contained three sections assessing the following: (1) Sociodemographic data; (2) Knowledge regarding counterfeit medicines; and (3) Ability to identify counterfeit medicines, according to 12 questions rated on a five-point Likert scale. Univariate and multivariate logistic regression analyses were used to assess the association between sociodemographic factors and counterfeit medication identification rate.Results: A total of 320 people participated in the study. Only 98 participants (30.6%, 95% CI 25.6–35.7%) identified the counterfeit medications. Ability to correctly identify counterfeit medications was significantly higher in participants who were older (p = 0.016), single (p = 0.001), Asian (p = 0.001), or American (p = 0.019), as well as those who indicated that they would check the certification of the medications (p = 0.015) and report counterfeit medications to the authorities (p < 0.0001).Conclusions: These results underscore the need for greater public awareness of the hazards associated with counterfeit medicines.

Content analysis of the official documents on the turnover of counterfeit medicines in Ukraine in 2017–2020

The purpose of the work was to conduct a content analysis of the orders of the State Medicines Service on the prohibition of the circulation of counterfeit medicines and the information messages of law enforcement agencies in 2017–2020. The object of the study was the orders of the State Medicines Service on the prohibition of the circulation of counterfeit medicines, information messages of law enforcement agencies to identify the facts of clandestine production and counterfeiting, publications on the problems of it’s distribution. The study used the methods of content analysis, systematization and generalization. Тo prevent the circulation of counterfeit medicines in the countries of the world, various methods of countering counterfeiting are being introduced, however, only in Ukraine was the restriction of measures of state supervision (control) in the pharmaceutical sector introduced as an element of deregulation. In connection with this, it was investigated how such restrictions, which were introduced three times, has influenced the identification and distribution of counterfeit medicines. For the study, a methodology for content analysis of official documents on the circulation of counterfeit medicines in the country for 2017–2020 has been proposed. In most of the orders of the State Medicines Service, revealed signs of drug falsification were introduced, which related to the labeling of packages. The imposition of a moratorium on planned measures of state supervision had a negative impact on the work of quality control bodies of medicines to identify counterfeits. In 2010–2014 (before the introduction of the first moratorium) the State Medicines Service issued 326 orders prohibiting the circulation of counterfeit medicines, but after the introduction of the moratorium, the number of orders for 6 years decreased significantly – to 118. So, in 2020, the State Medicines Service issued only 4 orders to prohibit the circulation of counterfeit drugs (for comparisons in 2017 – 18), although law enforcement officers revealed 6 facts of clandestine production and counterfeit. According to the results of the study, it was established that it was necessary to unify and standardize the management documents of the State Medicines Service on the prohibition of the circulation of counterfeit medicines, and also indicated the feasibility of introducing «field screening» of the often counterfeited medicines, to establish the real part of counterfeit medicines. Information messages from law enforcement agencies should not be limited only to the facts of revealing clandestine proceedings, but also should contain the results of court decisions on these facts. It is advisable to intensify interaction with regulatory authorities in other countries for a more effective exchange of information on detected of counterfeit medicines.

Combatting Substandard and Counterfeit Medicines in the Nigerian Drug Market: How Industrial Pharmacists Can Rise Up to the Challenge

Substandard and counterfeit medicines (SCMs) are a major public health threat in Africa. In Nigeria, the manufacture and distribution of substandard and counterfeit medicines in the drug market are booming, despite the efforts of law enforcement agencies to crack down on criminal syndicates over the years. The current situation has been exacerbated due to factors tied to unregulated open drug markets, lack of counterfeit detection technology, poor local pharmaceutical manufacturing capacity, and porous cross-border monitoring and surveillance systems. However, industrial pharmacists have a key role to play in combatting the production and circulation of SCMs in the Nigerian drug market. In this commentary, we examine the prevalence of SCMs in Nigeria and proffer feasible recommendations that industrial pharmacists can leverage to ensure its effective containment.

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.

Block Chain in Fake Product Identification System Using QR Code

Every popular brand has fake manufacturers selling a counterfeited item at cheaper rates. Mostly counterfeiting medicine are selling to customer. For these factors combined with block chain technology can lead to an efficient comprehensive approach to reduce counterfeiting. Pharmaceutical organizations face many challenges regarding counterfeit medicines. Detecting fault medicines so that it will save public life. To discover the consciousness of the fake medication issue which requires an expanding security level for the appropriation of lawful pharmaceutical items. Manufacturing to user can be recorded, and the user is assured that the scans weren’t faked. The fake products can be identified by using QR code and it handles the product data

Analysis of the effectiveness of regulatory legal acts on counterfeiting of medicines in Ukraine

The problem of medicines counterfeiting is relevant for all countries of the world, without exception. At the same time, the effectiveness of combating the spread of counterfeit medicines (CM) in different countries, as well as the volume of counterfeited medical products, varies. Any state that aimed to ensure highly effective control over the circulation of medicines has to elaborate a comprehensive solution to this problem, primarily to adopt high-quality national legislation. The executive authorities should not only pay attention to neutralizing CM problem, but also take the most active part in this process. The primary role here should be played by law enforcement authorities. There is a need for coordinated work by law enforcement authorities to investigate the cases of falsified medicines and clandestine production, as well as by regulatory bodies to identify such products. It is also necessary to systematize the investigative and judicial practice on this issue, create an unified system for recording the facts of identifying the counterfeit drugs. The need for systematic monitoring and analysis of regulatory legal acts regarding the counteraction to the circulation of the CM in order to assess their effectiveness, as well as the adoption of appropriate measures by the authorized bodies, determine the relevance of the study. The aim of the work was to analyze the laws and regulations of CM adopted in Ukraine after the Declaration of Independence had been signed (1991), to assess their effectiveness in terms of bringing perpetrators to justice for pharmaceutical counterfeiting. Materials and methods. Scientific publications on the problem of CM, as well as the Laws of Ukraine and legal acts adopted by various authorities to combat the spread of falsified medicines, reports of law enforcement agencies, the General Prosecutor’s Office, the State Judicial Administration, court decisions included in the Unified State Register of Court Decisions (USRCD) under Article 321-1 of the Criminal Code of Ukraine. The analysis of the respective norms of the legislation adopted during 1991–2020 is carried out. Results. Having analyzed the reports of law enforcement agencies, the State Statistical Office, and the Prosecutor General’s Office, the authors established that none of the people who had been convicted under Article 321-1 of the Criminal Code of Ukraine, after the entry of the guilty verdict into force, was in places of deprivation of liberty. There are many information sources that provide various forms of statistics, but understanding them is quite a challenge. A large number of criminal proceedings have been investigated for a long time, and since the USRCD is inaccessible, and is available only for the pre-trial investigation bodies and the prosecutor’s office, it is impossible for a private person to get information regarding the end of the pre-trial investigation in certain cases. Conclusions. Despite the large quantity of regulatory legal acts adopted in Ukraine to prevent the spread of counterfeit medicines, the severity of the sanctions of Article 321-1 of the Criminal Code, which criminalizes the falsification and circulation of medicines, as well as the importance of medicines’ counterfeiting for public health, the effectiveness of measures to combat this phenomenon is dramatically low.