Coregulation Supervision Strategy of Drug Enterprises under the Government Reward and Punishment Mechanism

Considering the government reward and punishment mechanism and the collusion behavior between third-party testing agencies and drug enterprises, based on the coregulation information platform, this paper constructs an evolutionary game model of coregulation supervision, which involves the participation of local government, drug enterprises, and third-party testing agencies. The stable equilibrium points of each participant’s strategic choices are solved. The stability of the strategic combination is analyzed by Lyapunov’s first method, and MATLAB 2020b is used for simulation analysis to verify the influence of each decision variable on different players’ strategic choices. The results show that, firstly, the government-increased awards and penalties will promote the integrity of drug enterprises and noncollusion of third-party testing agencies, but it is not conducive to strict performance of regulatory responsibilities by the local government. Secondly, the provision of real drug test reports by third-party testing agencies to the coregulation information platform can supervise drug enterprises and restrict local government to perform its duty. Thirdly, the central government’s punishment to the local government’s dereliction of duty is significant to enhancing the robustness of drug enterprises’ integrity operation. Furthermore, reasonably setting rewards and punishments and perfecting the coregulation information platform will help form a coregulation pattern of government supervision, self-discipline of drug enterprises, and social supervision. Finally, drug quality is highly related to whether drug enterprises operate with integrity. Standardizing coregulation supervision of drug enterprises’ integrity operation is the key to ensuring the safety of the source of drug quality. Therefore, this paper enriches and expands the theoretical basis of the coregulation supervision of drug enterprises’ integrity operation and proposes corresponding countermeasures and suggestions.

The current state of the pharmaceutical market of Ukraine, quality assurance and falfication of medicines

The aim of our article was the study of the current state of the pharmaceutical market of Ukraine in the context of the quality assurance of medicines and preventing the spread of falsified medicines (FM), the identification of the main problems in the field of circulation of medicines and the ways to solve them. It is established that the dynamic development of the pharmaceutical market and its high profitability cause problem of drug quality, increasing threats to the spread of FM in circulation and require the implementation of effective mechanisms for regulation of quality and safety of medicines. Analysis the annual official statistics of the State Service of Ukraine on Medicines and Drug Control for the period of 2008–2019 on the number of detected FM in circulation showed a steady trend of increasing FM and insufficient implementation of effective measures to combat them. The creation of effective quality assurance system of drugs and preventing the spread of FM need to improve the organization of state control of drug quality, strengthening criminal liability for falsification of drugs and optimization of the system of their detection.

A Journey through the History of Drug Quality Control, from Greece to Costa Rica

This review describes the evolution and development of drug quality control throughout different times in history. A bibliographic research was conducted from the database JSTOR from the University of Costa Rica. This database contains information from academic journals and books from XIX to date. It covers different fields, such as anthropology, arts, biology, botany, health sciences, politics, pharmacy, history. Information was retrieved when the following words were present: pharmacy, quality, quality control, drugs, medicines, pharmacopoeia. In ancient history India, China, Greece, Egypt, Africa and America used different medicinal plants to cure or alleviate disease. In some of these regions, methods were developed to make medicinal preparations as safe and effective as possible. In ancient Greece, the need to have a complete knowledge of drugs to carry out their proper preparation and detect adulterations was emerging. In Europe there was a constant development in the field, from books containing simple lists of preparations and medicines to more complex pharmacopoeias that included quality of the medicines. In America, the United States Pharmacopoeia (USP) first appeared in 1820. In Costa Rica, the Specialized Laboratory for Drug Analysis, actually the Laboratory for Analysis and Pharmaceutical Consulting (LAYAFA), was created in 1965, to ensure the quality and safety of medicines registered and marketed in Costa Rica. Differences between regulations and quality standards across centuries and countries, and their impact on the commercialization of medicines, have promoted regulations to harmonize the requirements related to different activities of the processes of manufacture, registration and quality control of medicines.

ANALYSIS OF INDUSTRIAL PRACTICE OF DRUG QUALITY RISK MANAGEMENT IN RUSSIAN PHARMACEUTICAL ENTERPRISES

The aim of the research was to study the current industrial practice of drug quality risk management in Russian pharmaceutical enterprises, including the assessment of the main problems during the implementation of the risk management system and its compliance with the accepted international approaches.Materials and methods. In the period from 6 April to 10 May 2020, an online survey of the leading employees in the field of quality assurance of Russian manufacturers was conducted. In the survey, the questionnaire was based on the results of the authors’ analysis of the national regulatory legal acts of the Russian Federation, the European Union countries, international guidelines of the EAEU, ICH and WHO in this area. 111 people took part in the survey, the return of questionnaires was 11.5%.Results. The data obtained indicate the prevalence of a superficial approach to quality risk management in the Russian pharmaceutical industry, the presence of objective and subjective reasons that hinder the effective implementation of these methods, the fragmentation of the systems used and, in most cases, their ineffective use. The respondents believe that the most significant reasons for the difficulties in implementing this methodology, are the lack of recommendations from the Ministry of Industry and Trade of Russia on creating an effective quality risk management system and a shortage of the specialists who are ready to work in the area of this industry. The survey revealed rather large gaps in the deployment of a risk management system at the enterprise and separation from the established international practice.Conclusions. The data obtained indicate the extreme urgency of developing recommendations for a quality risk management system, which should be based upon and supported by Russian regulatory legal acts and international experience in this area. The authors propose highlights for these recommendations.

Increase of constant weight rates of weighing bottles and evaporating dishes in a pharmacological experiment

Improving the constant weight rates of weighing bottles and evaporation dishes is beneficial to drug quality control. When different quantities of weighing bottles were dried under the same conditions, the greater the quantity is, the lower the constant weight rate will be. When quantities are controlled to be the same, weighing bottles that have been cooled for 50 minutes have higher constant weight rates than those cooled for half an hour. Without being affected by other factors, weighing bottles? constant weight rates are higher when the bottles are dried at the temperature of 180?C than 105?C. The rate increases when the bottled are dried for 8 hours instead of 5 hours. After soaking for 48 hours in the solution of 2% HNO3 + 6% HCl, the weighing bottles and evaporating dishes gain higher constant weight rates. Being more efficient, faster, economical and practical, this experiment has improved the method to increase constant weight rates of weighing bottles and evaporating dishes, without the need of auxiliary equipment, and thus increased the accuracy of drug weighing results.