Activity of the Medicines and Medical Devices Agency of Serbia (ALIMS) includes, among others, the tasks of monitoring marketing and consumption of medicinal products.
Law on Medicines and Medical Devices of Serbia (“Official Gazette”, No. 30/2010) has stipulated the responsibilities of the Agency in the collection and processing of data on marketing and consumption of medicinal products and medical devices, as well as of wholesale license holders for medicinal products, who are obliged to keep records on the type and quantity of medicinal products sold in the Republic of Serbia, as well as on imported and exported medicinal products per individual package.
ALIMS is required to collect and process data on marketing and consumption of medicinal products in one calendar year. These reports are classified information, and processed data is available to the public.
Data collected for a specific time period is processed in accordance with the recommendations of the World Health Organization and methodology which ensures the obtaining and displaying of financial and statistical indicators of health and pharmacoeconomic and epidemiological indicators of medicinal product use in our community.
In order to obtain this data, the volume of medicinal product consumption is transferred into a number of Defined Daily Doses per 1000 inhabitants per day, according to the methodology established at the international level.
Defined Daily Dose (DDD) is a technical, statistical unit of measure of medicinal product use, the value of which represents the average daily dose for the main indication of medicinal product administration in adults whereby it is not dependent on the price, form, strength or size of medicinal product packaging and does not reflect the recommended or actual used dose of the medicinal product.
Number of DDD/1000 inhabitants per day provides an insight into the number of inhabitants (of 1,000) who have used the observed medicinal product and have been exposed to its effects during one day. Obtained data is placed in correlation to the number of inhabitants who have used the medicinal product for a period in process. Data on the number of inhabitants is taken from official documents of the Statistical Office of the Republic of Serbia.
Medicinal product use includes marketing, distribution, prescription and use of medicinal products in the community, with special emphasis on medical, social and economic consequences.
Monitoring of prescription and use of medicinal products contributes significantly to the assessment of pharmacotherapeutic attitudes and prescription habits in practice, and enables establishing of the factors that influence excessive or insufficient use of certain medicinal products.
An internationally valid uniform system of classification for medicinal products and consumption and a costs measurement system are needed for a comparison of consumption and costs of medicinal products in different geographic areas which use different active substances and different packaging. The ATC/DDD system was proven useful in overcoming these differences and the WHO recommends it as a European standard since 1981, and as the world standard since 1996.
The ATC system is a classification system which divides medicinal products into groups according to the organs or systems they affect consistent with their chemical, pharmacological and therapeutic properties. Each substance is identified by a specific alphanumeric code, so it is possible to group those with similar characteristics in the ATC levels.
Data on consumption and costs of medicinal products in primary health-care may originate from different levels of the distribution chain, for example:
• Data on sale obtained from pharmaceutical companies and/or wholesaler,
• Data on issued medicinal products obtained from pharmacies,
• Data on compensation obtained from state health-care services, social insurance and third parties, and
• Data on prescriptions issued by general practitioners and other prescribers.
Information on the consumption level for one medicinal product or set of medicinal products in a geographic area (country or region) is obtained by expressing consumption in DDD. Expression of consumption in DDD/1000 inh./day provides estimates of medicinal product use in that area, which is independent of population size, and which allows the comparison of areas with different population.
Cost indicators can include the following:
• Costs of medicinal products as per total health-care costs;
• Costs of medicinal products per capita;
• Costs of medicinal products per DDD;
• Costs of generic medicinal products as per total health-care costs;
• Consumption of generic medicinal products as per total medicinal product consumption;
• Costs of new medicinal products as per total health-care costs;
• Consumption of new medicinal products as per total medicinal product consumption;
• First 10 pharmacological classes to the second ATC level;
• First 10 INN to the fifth ATC level.
The ratio between medicinal product costs and total health-care costs provides an assessment of the economic burden on health-care systems by medicinal product consumption. The increase in pharmaceutical costs also raises an issue on financing the health-care systems.
Analysis of a medicinal product use is an instrument of quality assurance and is used for monitoring and evaluating the use of medicinal products by agreed criteria/standards, and if necessary, it can be used to recommend changes in practice in order to improve the quality, safety and profitability of prescribed medicinal products.
This process can be conducted retrospectively, prospectively or concurrently. Analysis of a medicinal product use is commonly used as an instrument when the practice of prescribing medicinal products is not harmonized with agreed standards.
Analysis of a medicinal product use enables the following:
• To verify the quality of prescribing in terms of safety, efficiency and costs to the organization,
• Improvement of the financial effects of therapy with reduced costs of inappropriate medicinal product use,
• Better quality of clinical pharmacy service in terms of clinical pharmacy practice and education benefits.