Research on the duration of Pharmaceutical Information life cycle
Iryna Timanyuk, Iryna Pestun, Mnushko Zoya
1C.Sc. in Pharmacy, Associate Professor, National University of Pharmacy, Ukraine
2D.Sc. in Pharmacy, Professor, National University of Pharmacy, Ukraine
3D.Sc. in Pharmacy, Professor, Kharkiv Medical Academy of Postgraduate Education,
Department of Management and Economics in Family Medicine, Ukraine
*Corresponding Author E-mail: timanjuk@gmail.com
ABSTRACT:
This article summarizes the arguments and counterarguments in the framework of a scientific discussion on aging information on an example of the pharmaceutical industry. The main purpose of the study is to analyze the rate of becoing obsolete of certain types of pharmaceutical information and determine the length of stages of its life cycle. The urgency of solving this scientific problem is that the processes of working with the information, its search, processing, updating, usage and storage require significant labor and material resources, therefore, the definition of the degree of importance of pharmaceutical information and the facilitation of a decision on the need for actualization or further storage of that or other information is one of the areas of scientific research. The study of the issue of aging information in the article is carried out in the following logical sequence: the pharmaceutical information is structured according to the degree of aging, The lifecycle of hardware that participates in work with information is considered; the level of electronic sources of pharmaceutical information is analyzed, the degree of updating and the frequency of the new information on drugs emergence and the frequency of changes to a number of basic regulatory acts that are used to regulate the pharmaceutical industry are reviewed. The methodical tools of the study were methods of analysis and synthesis, concretization and system analysis, the period of research covers the last 30 years. The object of research is the pharmaceutical industry, since on one hand it has a tempting rate of information aging and, on the other hand it has great social significance. The article presents the results of empirical analysis of information aging, which showed that the life cycle of information lasts for a certain time and is limited to two events – the approval and the expiry of the validity. The study empirically confirms and theoretically proves that the pharmaceutical information has its own life cycle, and some of its phases significantly affect the level of aging information. The results of the research can be useful for pharmaceutical companies as well as for specialists, because the availability of relevant information makes it possible to reduce the risks to the health and life of patients associated with the possibility of errors.
KEYWORDS: Pharmaceutical Information, life cycle of Information, Stages of the life cycle of Information.
INTRODUCTION:
MATERIAL AND METHODS:
According to the definition given in the Pharmaceutical Encyclopedia, the pharmaceutical information is the information needed for the proper performance of the pharmaceutical activity that is received and used by the pharmaceutical science and practice. Authors of the article distinguish normative-legal, statistical, informational-methodical, economic, pharmacoeconomic, information of managerial nature; information about the creation, use, circulation of drugs, other pharmaceutical and medical goods [1].
RESULTS:
The basic requirements for any information with no exception for pharmaceutical information include: utility or relevancy, authenticity, completeness, value, relevance and timeliness, comprehensibility, accessibility, ergonomics, convenience of form or volume in terms of the consumer in question, security, conciseness, etc. [2,3].
Work with information consists of the creation and dissemination of information, the formation of information resources and information consumption (fig.1).
Fig. 1 Life Cycle of Pharmaceutical Information
Recently, the concept of "life cycle", which is defined by the term of its existence, is used in the context of its relevance: in the short term, during a certain period or for a long time. The life cycle of information consists of the following stages:
· Birth of information - creation of the content itself; additionally, it is possible to include the creation of information carriers;
· Development (accumulation) of information - increase the volume of information and organization of information communications, recording information on certain information media;
· Information aging - reduction of volume, loss of certain links within the information content;
· Loss of information - reduction of information volume to zero bits, loss of semantic links and representation of information, destruction of information carriers [4,5].
The value of any information decreases over time. This happens due to the aging of information, that is, the loss of its usefulness to the consumer, which loses the sense of its use for their own needs. Information may become irrelevant after new data about the subject becomes obtained instead of the previous one. In other cases, the object itself may change so significantly that the information stops responding to it.
For quantitative assessment of the rate of information aging R. Barton and R. Keelbler, in analogy to the half-life period of radioactive substances, also introduced the concept of the "half-life period" of scientific articles, the time during which half of all documents used in the present are used for the selected event or phenomenon. Barton and Kepler defined the periods of half-life of publications in physics (4.6 years), mathematics (10.5), geology (11.8), chemistry (8.1), physiology (7.2), botany (10 years) that is, the rate of information aging is associated with the peculiarities of the development of each branch of science and technology [6,7].
American scientists conducted experimental studies to assess the aging of information in the 70's of the 20th century. As a research object, scientific and technical information stored in the funds of the National Library of Congress has been selected. The measure of the value of information contained in a particular work, was the number of requests for the information in question. As a result, the exponential nature of the fall in the value of information during a certain period of time was obtained.
The research on the evaluation of the aging of pharmaceutical information and the determination of the length of the life cycle of information used in the pharmaceutical industry has not been performed before. Overcoming the problems associated with the life cycle of information is an unresolved issue that requires a detailed study.
The purpose of the study is to analyze the rate of aging of certain types of pharmaceutical information and to determine the length of stages of its life cycle.
DISCUSSION:
All the studies mentioned above concerned the aging of scientific information. But pharmaceutical companies, in addition to scientific information, use regulatory, economic, marketing, statistical, and other types of information. By the degree of aging, all information can be divided into operational-tactical and strategic. According to the calculations of the scientists, operational-tactical information loses 10% of its initial value per day, strategic information loses 10% of its value per month [8,9].
Operational-tactical information of pharmaceutical companies can include market information, namely: commercial offers of suppliers, the price of the enterprise itself, orders and customer requests, in addition - information on the quality control of drugs, correspondence with business partners and regulatory bodies, etc.
The strategic information used by the operators of the pharmaceutical market includes financial and economic information on the results of the enterprise's activity, technological information (technological regulations), data on market analysis, projections for further development of the enterprise, regulatory acts used by market participants, etc.
According to the scientists, (V. S. Krayenko, V. L. Basanets), it is necessary to annually replace 10-20% of the available information due to the fact that it becomes obsolete, and the share of information that remains relevant in the general information flow in modern conditions does not exceed 10% [9].
Along with the fact that the process of the information aging itself is continuous, information technologies refer to the life cycle of technical means, computer programs, a site or portal, a communication lines that connect, for example, an Internet service provider and its user.
Over the past 30 years, there have been processes of loss of information through the change of types of media and technology of information exchange.
Until recently, paper documents used to be the main source for obtaining information from medical specialists. As sources of information, documents are divided into published, intended for widespread dissemination (brought to the public through the press); unpublished, not intended for widespread use (research reports, dissertations, deposited manuscripts, applications for inventions, etc.)., and those that are not intended for publication, containing the initial data for the compilation of new documents (report on the formulation, turnover for the preparation of the trade and financial plan, etc.) [3].
In recent years, electronic information resources have become increasingly important as a source for obtaining information about medicinal products by specialists. In the 80-90's of the last century, in demand were local information retrieval systems (IRS), which were developed and implemented in the work of individual pharmaceutical and medical institutions. Such IRS had numerous advantages over paper carriers: it facilitated the search for information, allowed it to be stored in a more compact form, and to be quickly printed out if necessary. But these IRS were incompatible with each other, the information exchange between them was either very complicated or impossible. The filling of such IRS was carried out by the operator by filling out the text fields and requiring considerable time expenditures. But already in the late 90's, due to the massive transfer of most users from the MS-DOS operating system to Microsoft Windows, most of these systems ceased to function and the information contained in them was lost.
Subsequently, with the development of the Internet, network resources became popular. At the moment, users have access to various sources of information in the Internet, from official databases created by government agencies and professional periodicals, designed exclusively by professionals, to resources such as Wikipedia, which is created, updated and adjusted by the users themselves. An important feature of the information provided on the Internet is the presence of active hypertext links to other sites containing information on this problem, which significantly extends the information search space. The reliability of such information depends on the source of its receipt, and efficiency - from the periodicity of the update.
According to the International Data Corporation (IDC), today, up to 80% of the information is created and processed in organizations, and existing methods for its storage and protection are becoming less effective. Information used by the organization is divided to storage levels to operational data, background information and information for archival storage [10].
The Information Lifecycle Management (ILM) process consists of migration of the information of different types and different values between several "levels of storage." The term "ILM" was widely known in 2003, owned by Storage Technology, later acquired by Sun Mirosystems. IDC analysts define ILM as "the migration of data of different classes to the corresponding storage systems according to their predicted value and criteria for cost, performance, availability, time of recovery, regulatory and organizational requirements" [10].
Let's consider in more detail the degree of renewal and the frequency of the emergence of new information on medicines and drugs. Such information can be classified as strategic.
According to the literature, the world market is annually replenished by several dozen drugs that contain a new active substance (NAS). In the last decade of the 20th century, 43 NAS appeared on average, 26 NAS will appear in the next 10 years, 42 NASs in the period of 2010-2018 [11-13]. Compared to the total number of NAS (about 2,000), the upgrade share is 1.3-2.2% annually. But, despite the small quantitative changes, it is the innovative drugs that lead to significant healthcare changes, opening up new prospects in the fight against serious illnesses.
According to the information published on the State Expert Centre (SEC) of the Ministry of Health of Ukraine, for the period of 2010-2015, 150 reference/ original medicines were registered for the first time in Ukraine on the basis of the full registration information provided. If divided by 6 years, it turns out that the appearance of absolutely new drugs in Ukraine is 0.25% of the total number of registered drugs [14].
In the process of applying a drug, new information about their properties and application features appears. The pharmacovigilance authorities of different countries and international organizations exchange such data for the purpose of making decisions on the prohibition of drugs, limiting the use for certain categories of patients or amending the guidelines in order to ensure the further medical use of drugs. According to the SEC of the Ministry of Health of Ukraine for the period 1996-2014, similar measures were applied to 29 drugs, namely, the medical use of 13 drugs was prohibited, the use for certain categories of patients was limited for 12 drugs, and significant changes were made to the instructions of 4 drugs [15]. The result of the pharmacovigilance is also the reflection of the received safety information in the instructions for medical use of the drug, including the harmonization of the instructions of the generic drug to the original. In accordance with mentioned above, in 2011, there were changes made to 1976 drugs instructions, in 2012 - 1597, in 2013 - 1506, in 2014 - 1475, in 2015 – 1061. This makes up 10-20% annually from the total number of drugs registered in Ukraine [14].
Normative legal information that is used to regulate the activities of the pharmaceutical industry can also be classified as strategic. The frequency of changes in a number of basic legal acts in recent years is to be analyzed.
The Law of Ukraine "On Medicinal Products", which was introduced by the Decree of the Verkhovna Rada of Ukraine No. 124/96-VR of 04.04.96, suffered from 25 changes during the time of existence. The largest changes were made in 2011 and in 2012 - 6 and 5 respectively. But during 2000-2005, as well as in 1998, 2008 and 2017, no changes were made to the law.
By Resolution of the Cabinet of Ministers of Ukraine of October 17, 2008, No. 955 "On Measures to Stabilize Prices for Medicinal Drugs and Medical Products", for the 10 years of its existence, changes were introduced 15 times, of which 4 times - in 2012. In addition, its action was suspended by the Decree of the President of Ukraine from December 2008 to April 2009.
The Order of the Ministry of Health of Ukraine dated 19.07.2005 No. 360 "On Approval of the Rules for Prescribing Prescriptions for Medicinal Drugs and Medical Products, the Procedure for the Issue of Medicinal Drugs and Medical Products from Pharmacies and their Departments, Instructions on the Procedure for Storage, Registration and Destruction of Prescription Forms" has changed 23 times To this document changes were made 2-3 times annually.
To the Order of the Ministry of Health of Ukraine dated October 31, 2011, No. 723 "On approval of licensing conditions for the conduction of economic activity for the production of medicinal products, wholesale, retail trade in medicinal products", during the period of its validity till May 11, 2017, 8 changes were made, 5 of them in 2012, the next year after the aproval of the order.
The document valid for today - Decree of the Cabinet of Ministers No. 929 of November 30, 2016 "On Approval of Licensing Conditions for conducting business activities for the production of medicinal products, wholesale and retail trade in medicinal products, import of medicinal products (except for active pharmaceutical ingredients)" has not undergone any changes since the moment of approval.
CONCLUSIONS:
Thus, information on the properties of drugs and regulatory information in the pharmaceutical industry by the degree of aging can be attributed to the strategic type. Information on the properties of the drug is introduced during the development and implementation of drugs on the market. During the rotation in the pharmaceutical market, the development of this information is taking place, gradually the processes of aging occurs. The loss of information about the medical drugs can only take place in the case of a complete refusal to use the active substance. Such kind of information exists for a long time and is subject to minor changes.
The introduction of normative-legal information is connected to the creation and approval of certain normative-legal acts. The development of this information is due to changes in documents, suspension and renewal of their actions. When the degree of information aging becomes significant, the loss of validity of the document (loss of information) occurs, and instead another document emerges. That means, the life cycle of normative-legal information lasts for a certain time and is limited to two events - the approval and the loss of validity.
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Received on 05.03.2019 Modified on 25.04.2019
Accepted on 17.05.2019 © RJPT All right reserved
Research J. Pharm. and Tech. 2019; 12(9):4421-4425.
DOI: 10.5958/0974-360X.2019.00761.3